13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | EUCTR2006-005910-11-DE (EUCTR) | 08/05/2008 | 08/02/2008 | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | Spasticity in multiple sclerosis (MS) | Trade Name: Sativex Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 488 | Phase 3 | United Kingdom;Germany;Spain;Italy | ||
| 2 | EUCTR2006-005910-11-GB (EUCTR) | 09/01/2008 | 14/08/2007 | A two-phase, Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | A two-phase, Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | Spasticity in multiple sclerosis (MS) | Trade Name: Sativex Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2007-002138-13-GB (EUCTR) | 13/09/2007 | 14/06/2007 | A placebo controlled, parallel group, randomised withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term GW-1000-02 (Sativex®). | A placebo controlled, parallel group, randomised withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term GW-1000-02 (Sativex®). | Symptoms of spasticity in multiple sclerosis. | Trade Name: Sativex Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 4 | EUCTR2006-005910-11-CZ (EUCTR) | 29/08/2007 | 10/07/2007 | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | Spacticity in multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 488 | Phase 3 | Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2005-005265-11-FR (EUCTR) | 14/12/2006 | 27/10/2006 | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. | Relief of central neuropathic pain in subjects with multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 3 | France;Czech Republic;United Kingdom | ||
| 6 | EUCTR2005-005265-11-CZ (EUCTR) | 17/10/2006 | 24/08/2006 | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects. | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects. | Relief of central neuropathic pain in subjects with multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 312 | United Kingdom;Czech Republic;France | |||
| 7 | EUCTR2005-005265-11-GB (EUCTR) | 03/04/2006 | 24/02/2006 | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects | Relief of central neuropathic pain in subjects with multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;United Kingdom | ||
| 8 | EUCTR2004-002509-63-CZ (EUCTR) | 11/03/2005 | 04/02/2005 | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | Spasticity due to Multiple Sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Czech Republic | |||
| 9 | EUCTR2004-002509-63-GB (EUCTR) | 21/02/2005 | 23/02/2005 | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/A | Spasticity due to Multiple Sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 3 | Czech Republic;United Kingdom | ||
| 10 | NCT01606176 (ClinicalTrials.gov) | March 2002 | 21/5/2012 | A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin | A Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function. | Pain;Multiple Sclerosis | Drug: GW-1000-02;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United Kingdom |
| 11 | NCT01606137 (ClinicalTrials.gov) | February 2002 | 21/5/2012 | A Study of the Long-term Safety of Sativex Use | A Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine. | Multiple Sclerosis;Spasticity;Pain | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 507 | Phase 3 | United Kingdom |
| 12 | NCT01610687 (ClinicalTrials.gov) | July 2001 | 31/5/2012 | A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | A Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis;Spasticity | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 137 | Phase 3 | United Kingdom |
| 13 | NCT01610700 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients | Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis | Drug: GW-1000-02;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | United Kingdom |
| 14 | NCT01610713 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension | Multiple Sclerosis | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 154 | Phase 3 | United Kingdom |