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 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | EUCTR2020-004306-58-LT (EUCTR) | 28/01/2022 | 25/11/2021 | A study to asses the effects of Nabiximols on spasticity associated with multiple sclerosis. | A randomized double-blind placebo-controlled study of nabiximols in patients with spasticity in multiple sclerosis - RELEASE MSS4 | Symptomatic treatment of spasticity in patients with MS MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Hungary;Canada;Spain;Lithuania;Bulgaria;United Kingdom;Italy | ||
| 2 | EUCTR2020-003271-18-ES (EUCTR) | 01/07/2021 | 05/07/2021 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex 2,7mg/2,5 mg Solucion para pulverizacion bucal Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Czechia;Czech Republic;Poland;Belgium;Spain;Australia;United Kingdom;Sweden | ||
| 3 | EUCTR2020-003271-18-CZ (EUCTR) | 07/06/2021 | 07/04/2021 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Czechia;Czech Republic;Spain;Poland;Belgium;Australia;United Kingdom;Sweden | ||
| 4 | EUCTR2019-002625-29-CZ (EUCTR) | 18/05/2021 | 10/03/2021 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 3 | Czechia;Czech Republic;Poland;United Kingdom | ||
| 5 | EUCTR2019-002623-14-PL (EUCTR) | 15/04/2020 | 21/01/2020 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czechia;Czech Republic;Poland;Romania;United Kingdom | ||
| 6 | EUCTR2019-002623-14-CZ (EUCTR) | 17/03/2020 | 19/12/2019 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray (non-marketed) INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czechia;Czech Republic;Poland;Romania;United Kingdom | ||
| 7 | EUCTR2019-002625-29-GB (EUCTR) | 16/03/2020 | 18/06/2020 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis - Study in MS patient Naïve to treatment with Nabiximols | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Sativex Oromucosal Spray INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 3 | Poland;United Kingdom | ||
| 8 | EUCTR2019-002623-14-GB (EUCTR) | 24/02/2020 | 18/03/2020 | A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis | A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis - Nabiximols Oromucosal Spray as Add-on Therapy in Patients with MS | Symptomatic relief of spasticity in Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: UK: Sativex Oromucosal Spray Product Name: UK: Sativex Oromucosal Spray INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 446 | Phase 3 | United States;Czech Republic;Poland;Romania;United Kingdom | ||
| 9 | EUCTR2019-002625-29-PL (EUCTR) | 14/01/2020 | 21/11/2019 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 3 | Czechia;Czech Republic;Poland;United Kingdom | ||
| 10 | NCT03186664 (ClinicalTrials.gov) | December 28, 2016 | 7/6/2017 | The Role of SAtivex® in Robotic-Rehabilitation | The Role of SAtivex® Associated With Robotic-Rehabilitation in Improving the Motor Performances of Multiple Sclerosis Patients (SARR) | Rehabilitation | Device: Lokomat training;Drug: Sativex | IRCCS Centro Neurolesi Bonino-Pulejo | NULL | Completed | 18 Years | 65 Years | All | 40 | N/A | Italy |
| 11 | EUCTR2015-004451-40-AT (EUCTR) | 01/03/2016 | 14/01/2016 | SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICS | SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSTHE S A V A N T TRIAL - SAVANT | Moderate to severe spasticity due to MS (multiple sclerosis). MedDRA version: 19.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SATIVEX INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL INN or Proposed INN: TETRAHYDROCANNABINOL Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL | Almirall Hermal GmbH | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 4 | Czech Republic;Austria | ||
| 12 | EUCTR2015-004451-40-CZ (EUCTR) | 17/02/2016 | 22/12/2015 | SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICS | SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSTHE S A V A N T TRIAL - SAVANT | Moderate to severe spasticity due to MS (multiple sclerosis). MedDRA version: 19.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SATIVEX | Almirall Hermal GmbH | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 4 | Czech Republic;Austria | ||
| 13 | NCT01868048 (ClinicalTrials.gov) | October 2013 | 30/5/2013 | Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis. | A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis. | Spasticity;Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Research Ltd | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 14 | EUCTR2011-000985-36-ES (EUCTR) | 22/02/2013 | 25/01/2012 | Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex | Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex | Spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex MedDRA version: 14.1;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: SATIVEX Product Name: sativex Product Code: N02BG10 INN or Proposed INN: pending Other descriptive name: CANNABIDIOL | JOSE MANUEL GARCIA DOMINGUEZ | NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
| 15 | NCT01538225 (ClinicalTrials.gov) | April 2012 | 20/2/2012 | Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity | Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | Almirall, S.A. | NULL | Completed | 18 Years | N/A | Both | 45 | Phase 3 | Italy |
| 16 | NCT01964547 (ClinicalTrials.gov) | January 2012 | 15/10/2013 | A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients | A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple Sclerosis | Multiple Sclerosis;Spasticity | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 121 | Phase 4 | Czech Republic |
| 17 | EUCTR2011-002258-30-IT (EUCTR) | 04/10/2011 | 10/04/2012 | CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF Sativex in relieving pain PEOPLE AFFECTED BY MULTIPLE SCLEROSIS | NEUROPHYSIOLOGIC STUDY AIMED AT EVALUATING ON EFFECT OF SATIVEX® ON SPASTICITY IN PROGRESSIVE MULTIPLE SCLEROSIS - M/SATIVX/01 | Subject of both male and female gender affected by Secondary-Progressive (SP) or Primary-Progressive (PP) MS MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SATIVEX INN or Proposed INN: CANNABIDIOL INN or Proposed INN: DELTA-9-TETRAHYDROCANNABINOL | ALMIRALL PRODESFARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 18 | EUCTR2011-000926-31-CZ (EUCTR) | 29/06/2011 | 25/05/2011 | A long term, 50 week, Phase IV multi-centre study to determine if Sativex has an effect on cognition (thinking ability) when prescribed to patients with spasticity due to MS | A Multicentre, Double-blind, Randomised Parallel Group, Placebo- controlled Study of the Effect of long-term treatment with Sativex onCognitive Function and Mood of Patients with Spasticity due toMultiple Sclerosis | Spasticity in multiple sclerosis (MS). MedDRA version: 14.1;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex Oromucosal Spray INN or Proposed INN: N/A Other descriptive name: delta-9-tetrahydrocannabinol INN or Proposed INN: N/A Other descriptive name: cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Czech Republic | ||
| 19 | NCT02073474 (ClinicalTrials.gov) | February 2011 | 21/2/2014 | An Observational Post-Marketing Safety Registry of Sativex® | An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex® | Multiple Sclerosis;Diabetes;Cancer;Neuropathic Pain | Drug: Sativex® | GW Pharmaceuticals Ltd. | NULL | Completed | N/A | N/A | All | 978 | N/A | NULL |
| 20 | 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 | ||
| 21 | EUCTR2006-005910-11-IT (EUCTR) | 16/04/2008 | 23/04/2008 | 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. - Study of Sativex in subjects with spasticity due to MS | 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. - Study of Sativex in subjects with spasticity due to MS | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex INN or Proposed INN: Other analgesics and antipyretics | GW PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 488 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 22 | 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 | ||
| 23 | NCT00681538 (ClinicalTrials.gov) | January 2008 | 19/5/2008 | A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS) | 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;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 572 | Phase 3 | United Kingdom |
| 24 | NCT00702468 (ClinicalTrials.gov) | November 2007 | 19/6/2008 | Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis | A Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-term Sativex®. | Spasticity;Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 36 | Phase 3 | United Kingdom |
| 25 | 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 | ||||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | |||
| 29 | NCT00391079 (ClinicalTrials.gov) | September 2006 | 20/10/2006 | Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS | 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 | Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 339 | Phase 3 | Canada |
| 30 | 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 | ||
| 31 | NCT00202423 (ClinicalTrials.gov) | July 2005 | 12/9/2005 | Use of Cannabinoids in Patients With Multiple Sclerosis | fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex | S. Andrea Hospital | University of Roma La Sapienza | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 2 | Italy |
| 32 | 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 | |||
| 33 | NCT01599234 (ClinicalTrials.gov) | March 2005 | 10/5/2012 | A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis | A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis. | Multiple Sclerosis | Drug: Sativex;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 337 | Phase 3 | United Kingdom |
| 34 | 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 | ||
| 35 | EUCTR2005-000393-47-IT (EUCTR) | 22/09/2004 | 05/03/2007 | Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study. | Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-controlled, crossover study. | Treatment of spasticity in patients with Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Cannabis Based Medicine Extract (Sativex) | AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 36 | NCT00678795 (ClinicalTrials.gov) | August 2002 | 14/5/2008 | A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis | A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis. | Detrusor Overactivity;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 135 | Phase 3 | United Kingdom |
| 37 | NCT00711646 (ClinicalTrials.gov) | June 2002 | 8/7/2008 | A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis. | A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis. | Spasticity;Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 189 | Phase 3 | United Kingdom |
| 38 | NCT01604265 (ClinicalTrials.gov) | March 2002 | 21/5/2012 | A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis | A Double Blind, Randomised, Parallel Group, Placebo Controlled Study of Sativex in the Treatment of Central Neuropathic Pain in Multiple Sclerosis. | Multiple Sclerosis;Neuropathic Pain | Drug: Placebo;Drug: Sativex | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 66 | Phase 3 | United Kingdom |
| 39 | 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 |