Immediate release carbidopa/levodopa ( DrugBank: Carbidopa, Levodopa )


1 disease
IDDisease name (Link within this page)Number of trials
6Parkinson disease12

6. Parkinson disease


Clinical trials : 2,298 Drugs : 2,202 - (DrugBank : 350) / Drug target genes : 188 - Drug target pathways : 202
No.TrialIDDate_
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PhaseCountries
1EUCTR2015-003512-20-PL
(EUCTR)
22/06/201601/04/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
2EUCTR2015-003512-20-IT
(EUCTR)
08/06/201605/11/2020Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852
MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy
3EUCTR2015-003512-20-ES
(EUCTR)
18/05/201618/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients Parkinson's Disease
MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
4EUCTR2015-003512-20-HU
(EUCTR)
09/05/201602/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
5EUCTR2015-003512-20-GB
(EUCTR)
28/04/201603/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
6EUCTR2015-003512-20-SK
(EUCTR)
22/04/201604/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
7NCT00642356
(ClinicalTrials.gov)
March 200819/3/2008Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffAn 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartisNULLTerminated30 Years85 YearsAll14Phase 4United States
8EUCTR2005-001032-72-PT
(EUCTR)
23/03/200611/11/2005A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First StepA 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step Parkinson diseaseTrade Name: Stalevo
Product Code: ELC200
INN or Proposed INN: levodopa/carbidopa/entacapone
Trade Name: SINEMET
Product Name: sinemet
INN or Proposed INN: levodopa/carbidopa
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
9EUCTR2005-001032-72-CZ
(EUCTR)
16/02/200612/01/2006A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First StepA 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step Trade Name: Stalevo 100 mg/25 mg / 200 mg
Product Code: ELC200
Trade Name: SINEMET CR
Product Name: SINEMET CR
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
10EUCTR2005-001032-72-IT
(EUCTR)
25/11/200526/03/2007A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa.A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. Parkinson s Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Trade Name: Stalevo
INN or Proposed INN: ENTACAPONE INN
INN or Proposed INN: LEVODOPA INN
INN or Proposed INN: CARBIDOPA INN
Trade Name: Sinemet
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA ANIDRA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
11NCT00134966
(ClinicalTrials.gov)
August 200523/8/2005A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/LevodopaA 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring LevodopaParkinson's DiseaseDrug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)NovartisNULLCompleted30 Years80 YearsAll493Phase 3United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
12NCT00099268
(ClinicalTrials.gov)
September 200410/12/2004Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyA Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartis PharmaceuticalsOrion Corporation, Orion PharmaCompleted30 Years70 YearsAll747Phase 3United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom