Levodopa-Carbidopa Intestinal Gel (LCIG) ( DrugBank: Carbidopa, Levodopa )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病9

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_
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PhaseCountries
1EUCTR2014-004865-26-GR
(EUCTR)
01/08/201725/04/201726-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 3United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden
2NCT02799381
(ClinicalTrials.gov)
February 9, 201710/6/2016A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)Parkinson's Disease (PD)Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tubeAbbVieNULLCompleted30 YearsN/AAll63Phase 3United States;Finland;Greece;Hungary;Italy;Slovakia;Spain
3NCT02549092
(ClinicalTrials.gov)
October 26, 201511/9/2015A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS StudyAdvanced Parkinson's DiseaseDrug: Optimized Medical Treatment;Drug: Levodopa-Carbidopa Intestinal Gel;Device: Nasojejunal (NJ) tube;Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tubeAbbVieNULLCompleted30 YearsN/AAll89Phase 3United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
4EUCTR2014-004865-26-IT
(EUCTR)
21/09/201529/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88European Union;Canada;Spain;Australia;Germany;Italy;Sweden
5EUCTR2014-004865-26-DE
(EUCTR)
27/08/201522/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3European Union;Canada;Spain;Australia;Germany;Italy;Sweden
6EUCTR2014-004865-26-SE
(EUCTR)
05/08/201525/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
7EUCTR2014-004865-26-ES
(EUCTR)
19/06/201515/06/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3Greece;Canada;Sweden;European Union;Italy;Australia;Germany;Spain
8NCT01736176
(ClinicalTrials.gov)
March 201327/11/2012A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's DiseaseAn Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) TabletsAbbVie (prior sponsor, Abbott)NULLCompleted30 YearsN/AAll39Phase 3United States
9NCT00141518
(ClinicalTrials.gov)
March 200630/8/2005Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic ImpactA Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/DyskinesiaAdvanced Idiopathic Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube)AbbVie (prior sponsor, Abbott)NULLCompleted18 Years99 YearsAll77Phase 4Norway;Sweden