Apomorphine ( DrugBank: Apomorphine )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
5進行性核上性麻痺1
6パーキンソン病60
7大脳皮質基底核変性症1

5. 進行性核上性麻痺


臨床試験数 : 89 薬物数 : 107 - (DrugBank : 40) / 標的遺伝子数 : 65 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04786158
(ClinicalTrials.gov)
December 1, 20183/3/2021Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)Progressive Supranuclear Palsy;Corticobasal DegenerationDrug: ApomorphineFondation Ophtalmologique Adolphe de RothschildNULLCompleted18 YearsN/AAll7France

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04879134
(ClinicalTrials.gov)
February 28, 20224/5/2021Apomorphine Effects on Pain in Parkinson's DiseaseApomorphine Effect on Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Cross-over StudyParkinson DiseaseDrug: Apomorphine Injectable Solution;Drug: PlaceboUniversity of CalgaryPaladin Labs Inc.Recruiting18 Years70 YearsAll40Phase 2/Phase 3Canada
2NCT04887467
(ClinicalTrials.gov)
September 16, 202126/4/2021Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's DiseasePharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment.Parkinson DiseaseDrug: ApomorphineRennes University HospitalNULLRecruiting50 Years70 YearsMale20Phase 4France
3EUCTR2021-000826-89-FR
(EUCTR)
23/04/202125/03/2021Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitementEtude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: APOKINON
Product Name: APOKINON
Product Code: N04BC07
CHU RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
20Phase 4France
4EUCTR2019-003315-60-NL
(EUCTR)
10/11/202008/10/2020A study investigating the effect and safety of a new potential drug for Parkinson's disease patients.A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease - Buccal apomorphine (APORON) administration Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go
Product Name: APO-go®
INN or Proposed INN: Apomorphine
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Product Name: APORON
INN or Proposed INN: APORON
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Criceto IKM B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 1;Phase 2Netherlands
5NCT04157933
(ClinicalTrials.gov)
October 16, 20191/11/2019Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's DiseaseA Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's DiseaseParkinson's DiseaseDrug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossoverAlexza Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll35Phase 1Netherlands
6NCT03693872
(ClinicalTrials.gov)
May 15, 20191/10/2018Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsEvaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsParkinson DiseaseDrug: Apomorphine;Drug: Dopaminergic Agonist + ApomorphineRennes University HospitalNULLRecruiting18 YearsN/AAll42N/AFrance
7NCT03391882
(ClinicalTrials.gov)
December 19, 20182/1/2018A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor FluctuationsMotor OFF Episodes Associated With Parkinson's DiseaseDrug: APL-130277;Drug: subcutaneous apomorphineSunovionNULLCompleted18 YearsN/AAll113Phase 3Austria;France;Germany;Italy;Spain;United Kingdom
8NCT03822364
(ClinicalTrials.gov)
November 26, 201818/12/2018Staccato Apomorphine Single and Multi Dose PKA Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5Alexza Pharmaceuticals, Inc.NULLCompleted18 Years60 YearsAll56Phase 1Netherlands
9EUCTR2016-003456-70-IT
(EUCTR)
04/05/201802/02/2021A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Disease patientsAn Open-Label Randomized Crossover Trial, utilizing a Single-Blinded Rater to evaluate APL- 130277 compared to S.C. Apomorphine in Levodopa Responsive Subjects with Parkinson¿s Disease Complicated by Motor Fluctuations - A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Di Levodopa Responsive Patients with Parkinson¿s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
Product Code: n/a
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
SUNOVION PHARMACEUTICALS INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
10EUCTR2016-003456-70-DE
(EUCTR)
04/04/201803/04/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomor
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
11EUCTR2016-000637-43-IT
(EUCTR)
05/03/201821/01/2021Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patientswith Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes). - Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease. Levodopa Responsive Patients with Parkinson's Disease complicated by Motor Fluctuations (OFF Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: [APL-130277]
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: Apomorphine hydrochloride
Product Name: Apomorfina cloridrato
Product Code: [APL-130277]
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: Apomorphine hydrochloride
Product Name: Apomorfina cloridrato
Product Code: [APL-130277]
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: Apomorphine hydrochloride
Product Name: Apomorfina cloridrato
Product Code: [APL-130277]
INN or Proposed INN: APOMORFINA CLORIDRATO
Other descriptive name: Apomorphine hydrochloride
SUNOVION PHARMACEUTICALS INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy
12EUCTR2016-003456-70-ES
(EUCTR)
06/02/201807/12/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
85Phase 3Spain;Austria;United Kingdom
13EUCTR2016-000637-43-ES
(EUCTR)
06/02/201807/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom
14EUCTR2016-000637-43-AT
(EUCTR)
01/02/201815/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy
15NCT02940912
(ClinicalTrials.gov)
January 31, 201814/10/2016Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's DiseaseDouble Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's DiseaseParkinson DiseaseDrug: Apomorphine;Drug: PlaceboClinique Beau SoleilNULLActive, not recruiting35 Years90 YearsAll45Phase 4France
16EUCTR2016-003456-70-AT
(EUCTR)
04/01/201816/11/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomor
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
17NCT03292016
(ClinicalTrials.gov)
August 22, 201711/9/2017A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by OFF EpisodesA Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson DiseaseDrug: APL-130277;Drug: APO-go;Drug: ApokynSunovionNULLCompleted18 YearsN/AAll8Phase 2United States
18NCT02702076
(ClinicalTrials.gov)
May 20172/3/2016Apomorphine in Parkinson's Disease Patients With Visual HallucinationsRandomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual HallucinationsParkinson's Disease;Hallucinations, VisualDrug: Apomorphine;Drug: PlaceboUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll35Phase 2Netherlands
19EUCTR2016-003456-70-GB
(EUCTR)
22/03/201726/01/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorp
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;Italy;United Kingdom
20NCT02864004
(ClinicalTrials.gov)
March 3, 201715/7/2016Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)Apomorphine Pump in Early Stage of Parkinson's DiseaseParkinson's DiseaseDrug: Apomorphine;Other: Best Medical TreatmentRennes University HospitalNULLRecruiting18 Years65 YearsAll192Phase 3France
21EUCTR2016-000102-11-NL
(EUCTR)
23/11/201608/11/2016Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations.Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. - Apomorphine in PD patients with visual hallucinations: a RCT Parkinson's disease patients with refractory visual hallucinations
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: APO-go
Product Name: Apomorphine
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2;Phase 3Netherlands
22EUCTR2016-001762-29-IT
(EUCTR)
08/11/201625/05/2017A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes)A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) - CTH-201 Parkinson's Disease (PD)
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Trade Name: AVALOX - 400
SUNOVION PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Italy
23EUCTR2016-002454-20-FR
(EUCTR)
17/10/201616/03/2017Apomorphine Pump in Early Stage of Parkinson’s DiseaseApomorphine Pump in Early Stage of Parkinson’s Disease - EARLY-PUMP Parkinson’s disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: APOKINON
Product Name: APOKINON
CHU de RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3France
24NCT02688465
(ClinicalTrials.gov)
September 5, 201618/2/2016Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).Parkinson's DiseaseDrug: ApomorphineFondation Ophtalmologique Adolphe de RothschildNULLTerminated18 YearsN/AAll15Phase 4France
25EUCTR2016-000637-43-GB
(EUCTR)
12/05/201604/03/2016Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom
26EUCTR2016-000636-18-GB
(EUCTR)
12/05/201604/03/2016Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunuvion Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
126Phase 3Canada;United States;United Kingdom
27EUCTR2014-000657-36-NL
(EUCTR)
22/06/201503/06/2015Trial to investigate the efficacy of treatments in apomorphine-induced skin reactionsOpen-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Hydrocortisone cream 10mg/g FNA Fagron
Product Name: Hydrocortisone cream
Trade Name: Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial'
Product Name: Solu-Cortef
Trade Name: APO-go
Product Name: Apomorphine
University Medical Center GroningenNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands
28NCT02230930
(ClinicalTrials.gov)
June 201529/8/2014Treatment of Apomorphine-induced Skin Reactions: a Pilot StudyOpen-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin ReactionsParkinson's Disease;Apomorphine-induced Skin ReactionsDrug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mgUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll20Phase 2Netherlands
29NCT02339064
(ClinicalTrials.gov)
February 201531/3/2014Infusion of Apomorphine: Long-term Safety StudyA Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available TherapyIdiopathic Parkinson's DiseaseDrug: apomorphine infusionUS WorldMeds LLCNULLActive, not recruiting30 YearsN/AAll99Phase 3United States
30EUCTR2013-000980-10-DK
(EUCTR)
06/06/201409/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Austria;Denmark;Netherlands;Germany
31NCT02006121
(ClinicalTrials.gov)
March 3, 201422/11/2013Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's DiseaseMulticentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical TreatmentParkinson's DiseaseDrug: Apomorphine hydrochloride;Drug: PlaceboBritannia Pharmaceuticals Ltd.NULLCompleted30 YearsN/AAll107Phase 3Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom
32EUCTR2013-000980-10-FR
(EUCTR)
03/03/201422/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
STADA Arzneimittel AGNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
33EUCTR2013-000980-10-ES
(EUCTR)
12/02/201412/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
STADA Arzneimittel AGNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
34EUCTR2013-000980-10-NL
(EUCTR)
06/02/201427/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Germany;Netherlands
35EUCTR2013-000980-10-AT
(EUCTR)
18/10/201331/07/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
36NCT01504178
(ClinicalTrials.gov)
May 201130/12/2011Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's DiseaseEvaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's DiseaseParkinson's DiseaseDrug: duloxetine;Drug: placebo of duloxetine;Drug: injection of apomorphine;Drug: injection of placebo of apomorphine;Drug: L-Dopa;Drug: injection of placebo of L-DopaUniversity Hospital, ToulouseFrench Parkinson AssociationCompleted30 Years70 YearsAll28Phase 3France
37EUCTR2010-018650-12-FR
(EUCTR)
13/07/201006/05/2010Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOXEvaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX maladie de Parkinson
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: CYMBALTA
Product Name: duloxetine
Trade Name: APOKINON
Product Name: apomorphine
Trade Name: MODOPAR
Product Name: levodopa
Trade Name: MOTILIUM
Product Name: dompéridone
CHU de ToulouseNULLNot RecruitingFemale: yes
Male: yes
Phase 3France
38EUCTR2008-004447-11-GB
(EUCTR)
27/03/200907/01/2009A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s DiseaseA Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease
MedDRA version: 11;Level: LLT;Classification code 10067209;Term:
Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Germany;United Kingdom;Italy
39NCT00758368
(ClinicalTrials.gov)
March 200923/9/2008Comparison of Continuous and Pulsatile Apomorphine in Parkinson's DiseaseComparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced DyskinesiaParkinson's DiseaseDrug: ApomorphineOregon Health and Science UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Withdrawn21 YearsN/AAll0Phase 2United States
40EUCTR2008-006045-10-FR
(EUCTR)
06/02/200924/03/2009Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEPEffet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP L’objectif thérapeutique principal dans la maladie de Parkinson est de contrôler les fluctuations motrices. Cependant des fluctuations non motrices (FNM) sont fréquemment observées et semblent corrélées à la sévérité de la maladie. La stabilité dans le temps de l’efficacité du traitement dopaminergique est le moyen le plus pertinent pour améliorer les fluctuations tant motrices que non motrices.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: ApokinonCHU de RennesNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
41NCT01039090
(ClinicalTrials.gov)
February 200922/12/2009Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's DiseaseProspective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan StudyParkinsons's DiseaseDrug: Continuous Apomorphine infusion;Drug: Usual dopaminergic per os treatmentRennes University HospitalNULLCompleted18 YearsN/AAll21Phase 3France
42NCT00610103
(ClinicalTrials.gov)
November 200722/1/2008Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa TherapyA Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: apomorphine hydrochlorideKyowa Kirin Co., Ltd.NULLCompleted20 YearsN/AAll16Phase 2Japan
43NCT00524914
(ClinicalTrials.gov)
September 20074/9/2007Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging StudyApomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.Parkinson's DiseaseDrug: apomorphine;Drug: placeboUniversity Hospital, ToulouseNULLCompleted30 Years70 YearsBoth16N/AFrance
44EUCTR2006-005318-11-FR
(EUCTR)
06/07/200710/05/2007Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons.Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. maladie de Parkinson
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: APOKINONCHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
45NCT00489255
(ClinicalTrials.gov)
May 200720/6/2007Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and TreatmentA Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent Off Episodes, With Phased Withdrawal of Subjects From Tigan® to PlaceboParkinson's DiseaseDrug: Tigan®;Drug: PlaceboIpsenINC Research LimitedCompleted18 YearsN/AAll117Phase 4United States
46EUCTR2006-005509-79-GB
(EUCTR)
21/12/200607/12/2006A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s DiseaseA Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periodsProduct Name: apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United Kingdom
47EUCTR2006-004582-33-GB
(EUCTR)
03/11/200623/01/2012A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s DiseaseA Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease Hypomobility (off or freezing) episodes associated with advanced Parkinson's diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
48Phase 2United Kingdom
48EUCTR2006-000391-32-NL
(EUCTR)
18/07/200610/05/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Germany;Netherlands;United Kingdom
49EUCTR2006-000391-32-DE
(EUCTR)
04/07/200627/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's DiseaseProduct Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Netherlands
50NCT00346827
(ClinicalTrials.gov)
July 200629/6/2006Apomorphine Nasal Powder in the Treatment of Parkinson's Disease Off Periods.Parkinson's DiseaseDrug: Apomorphine Nasal PowderBritannia Pharmaceuticals Ltd.NULLCompleted18 Years85 YearsAll36Phase 2/Phase 3NULL
51EUCTR2006-000391-32-GB
(EUCTR)
06/06/200621/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Netherlands;Germany;United Kingdom
52NCT01683292
(ClinicalTrials.gov)
January 20067/9/2012Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's DiseaseAn Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's DiseaseParkinson's DiseaseDrug: Inhaled VR040;Drug: Placebo for VR040South Glasgow University Hospitals NHS TrustVectura LimitedCompleted30 YearsN/ABoth29Phase 2United Kingdom
53EUCTR2005-005120-13-GB
(EUCTR)
21/12/200502/11/2005A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s DiseaseA clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom
54NCT00472355
(ClinicalTrials.gov)
October 200510/5/2007Low Dose Apomorphine and ParkinsonismDoes Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?Parkinson's DiseaseDrug: apomorphineOregon Health and Science UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Withdrawn35 Years85 YearsAll0Phase 2United States
55NCT00040209
(ClinicalTrials.gov)
June 200221/6/2002JP-1730 to Treat Parkinson's DiseaseAlpha-2 Adrenergic Antagonist Treatment of Parkinson's DiseaseParkinson DiseaseDrug: JP 1730;Drug: IV Levodopa;Drug: IV ApomorphineNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth30Phase 2United States
56NCT00200525
(ClinicalTrials.gov)
July 200113/9/2005Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons DiseaseA Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing-Off Effects Associated With Late-Stage PD After Apomorphine UseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth60Phase 3NULL
57NCT00145171
(ClinicalTrials.gov)
February 20012/9/2005A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg.Parkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth56Phase 3NULL
58NCT00200512
(ClinicalTrials.gov)
September 199913/9/2005Continued Efficacy of Apomorphine After Previous Exposure of at Least Three MonthsA Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing Off Effects Associated With Late Stage Parkinson's DiseaseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth16Phase 2/Phase 3United Kingdom
59NCT00142545
(ClinicalTrials.gov)
July 199931/8/2005Long Term Safety and Efficacy of SC Apomorphine in Treatment of Off Episodes in Late-Stage Parkinson's DiseaseLong-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off” Episodes in Patients With On-Off” or Wearing-Off” Effects Associated With Late-Stage Parkinson’s DiseaseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth800Phase 3United States
60EUCTR2008-004447-11-DE
(EUCTR)
17/10/2008A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s DiseaseA Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease
MedDRA version: 11;Level: LLT;Classification code 10067209;Term:
Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Germany;Italy;United Kingdom

7. 大脳皮質基底核変性症


臨床試験数 : 16 薬物数 : 28 - (DrugBank : 13) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 38
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04786158
(ClinicalTrials.gov)
December 1, 20183/3/2021Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)Progressive Supranuclear Palsy;Corticobasal DegenerationDrug: ApomorphineFondation Ophtalmologique Adolphe de RothschildNULLCompleted18 YearsN/AAll7France