6. パーキンソン病 Parkinson disease Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000040889 | 2020/06/24 | 24/06/2020 | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease | Parkinson's disease | Levodopa-carbidopa continuous infusion gel (LCIG) therapy | Fujita Health University School of MedicineDepartment of Gastroenterology | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 200 | Phase 4 | Japan |
| 2 | JPRN-UMIN000037390 | 2019/07/01 | 16/07/2019 | An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy | An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy - Levodopa pharmacokinetics on concomitant use of LCIG therapy and COMT inhibitor | Parkinson's disease | Entacapone 100mg | Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine | Saiseikai Matsuyama Hospital | Pending | 20years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 3 | NCT03419806 (ClinicalTrials.gov) | February 16, 2018 | 10/1/2018 | Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease | Levodopa Pharmacokinetics in Patients With Parkinson's Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa | Parkinson Disease | Drug: Infudopa i.v.;Drug: Infudopa s.c.;Drug: LCIG (Duodopa) | Vastra Gotaland Region | The Swedish Research Council;Dizlin Medical Design AB;Göteborg University | Completed | 30 Years | N/A | All | 25 | Phase 1 | Sweden |
| 4 | EUCTR2014-004865-26-GR (EUCTR) | 01/08/2017 | 25/04/2017 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden | ||
| 5 | NCT02799381 (ClinicalTrials.gov) | February 9, 2017 | 10/6/2016 | A 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 tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 63 | Phase 3 | United States;Finland;Greece;Hungary;Italy;Slovakia;Spain |
| 6 | EUCTR2015-002631-17-ES (EUCTR) | 19/11/2015 | 03/11/2015 | A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients | An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa Product Name: Duodopa Trade Name: Sinemet Plus Product Name: Sinemet Plus | Institut de Recerca del Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 7 | NCT02549092 (ClinicalTrials.gov) | October 26, 2015 | 11/9/2015 | A 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 Study | Advanced Parkinson's Disease | Drug: Optimized Medical Treatment;Drug: Levodopa-Carbidopa Intestinal Gel;Device: Nasojejunal (NJ) tube;Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 89 | Phase 3 | United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden |
| 8 | EUCTR2014-004865-26-IT (EUCTR) | 21/09/2015 | 29/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | |||
| 9 | EUCTR2014-004865-26-DE (EUCTR) | 27/08/2015 | 22/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | 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 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 10 | EUCTR2014-004865-26-SE (EUCTR) | 05/08/2015 | 25/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | 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 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 11 | EUCTR2014-004865-26-ES (EUCTR) | 19/06/2015 | 15/06/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | 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 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | Greece;Canada;Sweden;European Union;Italy;Australia;Germany;Spain | ||
| 12 | NCT02604914 (ClinicalTrials.gov) | May 2015 | 3/11/2015 | A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects | 1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal Gel | Parkinson's Disease | Drug: ND0612;Drug: LCIG | NeuroDerm Ltd. | Quotient Clinical | Completed | 30 Years | 65 Years | All | 36 | Phase 1 | United Kingdom |
| 13 | NCT02274324 (ClinicalTrials.gov) | October 2014 | 22/10/2014 | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease | Parkinson Disease | Dietary Supplement: different diets | Sheba Medical Center | Tel Aviv University | Not yet recruiting | 40 Years | 80 Years | Both | 20 | N/A | NULL |
| 14 | NCT01736176 (ClinicalTrials.gov) | March 2013 | 27/11/2012 | A 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 Disease | An 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 Disease | Advanced Parkinson's Disease | Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets | AbbVie (prior sponsor, Abbott) | NULL | Completed | 30 Years | N/A | All | 39 | Phase 3 | United States |
| 15 | NCT00660387 (ClinicalTrials.gov) | December 2009 | 15/4/2008 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 35 | Phase 3 | United States;New Zealand |
| 16 | NCT00357994 (ClinicalTrials.gov) | January 2009 | 27/7/2006 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 36 | Phase 3 | United States;Germany |
| 17 | NCT00141518 (ClinicalTrials.gov) | March 2006 | 30/8/2005 | Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact | A 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-/Dyskinesia | Advanced Idiopathic Parkinson's Disease | Drug: 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) | NULL | Completed | 18 Years | 99 Years | All | 77 | Phase 4 | Norway;Sweden |