PERAMPANEL ( DrugBank: Perampanel )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症6
6パーキンソン病4
144レノックス・ガストー症候群10

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03377309
(ClinicalTrials.gov)
December 1, 201914/12/2017Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis PatientsSafety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis PatientsAmyotrophic Lateral SclerosisDrug: FycompaAmerican University of Beirut Medical CenterNULLTerminated18 Years80 YearsAll6Phase 2Lebanon
2NCT03793868
(ClinicalTrials.gov)
December 4, 201828/12/2018Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral SclerosisPerampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Perampanel;Other: PlaceboMayo ClinicNULLCompleted18 Years70 YearsAll22Early Phase 1United States
3NCT03019419
(ClinicalTrials.gov)
April 24, 201710/1/2017Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 TrialsALSDrug: Perampanel;Drug: placeboTokyo Medical UniversityNULLCompleted40 Years78 YearsAll66Phase 2Japan
4JPRN-UMIN000025614
2017/04/2401/02/2017Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 TrialPerampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial - Perampanel for sporadic amyotrophic lateral sclerosis (ALS) Sporadic amyotrophic lateral sclerosisOnce daily perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks (Interventions)
Once daily perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks (Interventions).
Once daily placebo for 48 weeks (Control)
Department of Neurology, Tokyo Medical UniversityNULLComplete: follow-up complete40years-old78years-oldMale and Female60Phase 2Japan
5JPRN-UMIN000026221
2017/03/0201/03/2017Safety of perampanel in patients with motor neuron diseaseSafety of perampanel in patients with motor neuron disease - Safety of perampanel in patients with motor neuron disease amyotrophic lateral sclerosisOnce daily perampanel with dose escalation from 2mg to 8mg.Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female15Phase 1Japan
6NCT03020797
(ClinicalTrials.gov)
January 12, 201715/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Perampanel;Drug: Placebo Oral TabletStony Brook UniversityEisai Inc.Recruiting18 Years80 YearsAll60N/AUnited States

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
1NCT00566462
(ClinicalTrials.gov)
October 200729/11/2007Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECTAssessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECTParkinson's DiseaseDrug: perampanel;Drug: placeboEisai Inc.NULLTerminated30 YearsN/AAll1Phase 2United States
2NCT00505622
(ClinicalTrials.gov)
July 20079/7/2007Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: PerampanelEisai LimitedNULLTerminated30 YearsN/AAll328Phase 3France
3NCT00368108
(ClinicalTrials.gov)
August 200622/8/2006Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparatorEisai Inc.NULLCompleted30 YearsN/AAll752Phase 3United States;Canada
4NCT01634360
(ClinicalTrials.gov)
November 20043/7/2012Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor FluctuationsA 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period DyskinesiasParkinson's DiseaseDrug: PerampanelEisai Inc.NULLTerminatedN/AN/AAll185Phase 2NULL

144. レノックス・ガストー症候群


臨床試験数 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002321-35-BE
(EUCTR)
05/06/201825/04/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
2EUCTR2014-002321-35-IT
(EUCTR)
01/09/201720/01/2022A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness inpatients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With anOpen-Label Extension Phase of Perampanel as Adjunctive Treatment inSubjects at Least 2 years of Age With Inadequately Controlled SeizuresAssociated With Lennox-Gastaut Syndrome - - Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
INN or Proposed INN: PERAMPANEL
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
INN or Proposed INN: PERAMPANEL
Other descriptive name: PERAMPANEL
EISAI LIMITEDNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;Czechia;Korea, Democratic People's Republic of;Lithuania;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of
3EUCTR2014-002321-35-CZ
(EUCTR)
31/08/201726/05/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;Czechia;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Latvia;Japan;Korea, Republic of
4EUCTR2014-002321-35-LV
(EUCTR)
26/05/201709/05/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
5EUCTR2014-002321-35-HU
(EUCTR)
08/05/201720/04/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 19.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
6JPRN-JapicCTI-173536
13/12/201615/03/2017Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Lennox-Gastaut Syndrome (LGS)Intervention name : E2007
INN of the intervention : Perampanel
Dosage And administration of the intervention : 2 mg oral tablets and 0.5 mg/ml oral suspension
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Matching-placebo
Eisai Co., Ltd.NULLcomplete2BOTH142Phase 3Japan, Asia except Japan, North America, Europe, Oceania
7NCT02834793
(ClinicalTrials.gov)
December 13, 201613/7/2016Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 Years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut SyndromeLennox-Gastaut Syndrome (LGS)Drug: Placebo;Drug: PerampanelEisai Inc.NULLTerminated2 YearsN/AAll70Phase 3Czechia;India;Japan;Korea, Republic of;Australia;Belgium;United States;Austria
8NCT02307578
(ClinicalTrials.gov)
February 5, 20152/12/2014An Extended Access Program (EAP) for PerampanelAn Extended Access Program (EAP) for PerampanelPrimary Generalized Tonic-Clonic or Partial Onset Seizures;Lennox Gastaut SyndromeDrug: PerampanelEisai Inc.NULLAvailable1 YearN/AAllBelgium;Chile;Estonia;Hungary;Latvia;Lithuania;Poland;Spain
9EUCTR2014-002321-35-FR
(EUCTR)
21/02/2018A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Latvia;Japan;Italy;Korea, Republic of
10EUCTR2014-002321-35-PL
(EUCTR)
13/05/2017A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut SyndromeA Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome Seizures associated with Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: perampanel
Other descriptive name: PERAMPANEL
Trade Name: Fycompa
Product Name: perampanel
Product Code: E2007
INN or Proposed INN: Perampanel
Other descriptive name: PERAMPANEL
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
142Phase 3United States;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Latvia;Japan;Italy;Korea, Republic of