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

  
35 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05269628
(ClinicalTrials.gov)
March 202213/2/2022Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain PhenotypeMechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain PhenotypeMultiple Sclerosis;Sleep;PainDrug: Cannabidiol (CBD);Drug: Tetrahydrocannabinol (THC);Drug: Placebo CBD;Drug: Placebo THCTiffany J. Braley, MD, MSNational Center for Complementary and Integrative Health (NCCIH)Not yet recruiting18 Years65 YearsAll166Phase 2United States
2EUCTR2020-004306-58-LT
(EUCTR)
28/01/202225/11/2021A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 3United States;Hungary;Canada;Spain;Lithuania;Bulgaria;United Kingdom;Italy
3EUCTR2020-003271-18-ES
(EUCTR)
01/07/202105/07/2021A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3Czechia;Czech Republic;Poland;Belgium;Spain;Australia;United Kingdom;Sweden
4EUCTR2020-003271-18-CZ
(EUCTR)
07/06/202107/04/2021A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3Czechia;Czech Republic;Spain;Poland;Belgium;Australia;United Kingdom;Sweden
5EUCTR2019-002625-29-CZ
(EUCTR)
18/05/202110/03/2021A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
104Phase 3Czechia;Czech Republic;Poland;United Kingdom
6EUCTR2019-002623-14-PL
(EUCTR)
15/04/202021/01/2020A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czechia;Czech Republic;Poland;Romania;United Kingdom
7EUCTR2019-002623-14-CZ
(EUCTR)
17/03/202019/12/2019A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czechia;Czech Republic;Poland;Romania;United Kingdom
8EUCTR2019-002625-29-GB
(EUCTR)
16/03/202018/06/2020A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 3Poland;United Kingdom
9EUCTR2019-002623-14-GB
(EUCTR)
24/02/202018/03/2020A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czech Republic;Poland;Romania;United Kingdom
10EUCTR2019-002625-29-PL
(EUCTR)
14/01/202021/11/2019A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 3Czechia;Czech Republic;Poland;United Kingdom
11EUCTR2018-000001-23-CZ
(EUCTR)
13/01/202016/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol 25 mg/ml, oral drops
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLNot RecruitingFemale: yes
Male: yes
548Phase 3Hungary;Czech Republic;Spain
12EUCTR2018-002315-98-DK
(EUCTR)
06/12/201809/07/2018The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury.The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI Central neuropathic pain and spasticity
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol capsule 5 mg
Product Code: N/A
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Product Name: Dronabinol capsule 2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Aarhus UniversitetshospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2Denmark
13EUCTR2018-000001-23-ES
(EUCTR)
06/11/201823/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
548Phase 3Hungary;Spain
14EUCTR2018-000001-23-HU
(EUCTR)
25/10/201816/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol 25 mg/ml, oral drops
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLNot RecruitingFemale: yes
Male: yes
548Phase 3Czech Republic;Hungary;Spain
15EUCTR2015-004451-40-AT
(EUCTR)
01/03/201614/01/2016SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSSATIVEX® 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
228Phase 4Czech Republic;Austria
16EUCTR2011-002258-30-IT
(EUCTR)
04/10/201110/04/2012CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF Sativex in relieving pain PEOPLE AFFECTED BY MULTIPLE SCLEROSISNEUROPHYSIOLOGIC 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 PRODESFARMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
17EUCTR2011-000926-31-CZ
(EUCTR)
29/06/201125/05/2011A 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 MSA 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 4Czech Republic
18EUCTR2010-022033-28-NL
(EUCTR)
10/01/201126/10/2010A study investigating safety, tolerability and efficacy of ECP002A (?9-THC) in Multiple Sclerosis patients suffering from spasticity and pain.A two-phased, randomized, double blind, placebo-controlled study of ECP002A (?9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain. - ECP002A (?9-THC) in MS patients 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]
Product Name: Namisol
Product Code: ECP002A
INN or Proposed INN: dronabinol
Other descriptive name: Namisol
Echo Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
Netherlands
19EUCTR2006-005910-11-DE
(EUCTR)
08/05/200808/02/2008A 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.NULLNot RecruitingFemale: yes
Male: yes
488Phase 3United Kingdom;Germany;Spain;Italy
20EUCTR2006-005910-11-GB
(EUCTR)
09/01/200814/08/2007A 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.NULLNot 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): noCzech Republic;Spain;Germany;Italy;United Kingdom
21EUCTR2007-002138-13-GB
(EUCTR)
13/09/200714/06/2007A 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.NULLNot RecruitingFemale: yes
Male: yes
United Kingdom
22EUCTR2006-005910-11-CZ
(EUCTR)
29/08/200710/07/2007A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
488Phase 3Czech Republic;Spain;Germany;Italy;United Kingdom
23NCT00959218
(ClinicalTrials.gov)
June 200713/8/2009Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple SclerosisMulti-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic PainCentral Neuropathic Pain in Multiple SclerosisDrug: Dronabinol;Drug: PlaceboBionorica Research GmbHNULLCompleted18 Years70 YearsBoth240Phase 3Germany
24EUCTR2006-004255-38-DE
(EUCTR)
17/01/200720/02/2007Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic painMulti-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain Patients with multiple sclerosis associated with central neuropathic pain
MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain
Product Name: dronabinol
Product Code: cnp-MS-0601
INN or Proposed INN: dronabinol
Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol
Bionorica research GmbHNULLNot RecruitingFemale: yes
Male: yes
240Austria;Germany
25EUCTR2006-004255-38-DK
(EUCTR)
15/01/200718/12/2006Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central painMulti-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain Patients with multiple sclerosis associated with central neuropathic pain
MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain
Product Name: dronabinol
Product Code: cnp-MS-0601
INN or Proposed INN: dronabinol
Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol
Bionorica research GmbHNULLNot RecruitingFemale: yes
Male: yes
240Phase 3Austria;Denmark;Germany
26EUCTR2006-004255-38-AT
(EUCTR)
05/01/200706/11/2006Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic painMulti-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain Patients with multiple sclerosis associated with central neuropathic pain
MedDRA version: 16.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852
Product Name: dronabinol
Product Code: cnp-MS-0601
INN or Proposed INN: dronabinol
Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol
Bionorica research GmbHNULLNot RecruitingFemale: yes
Male: yes
240Austria;Germany
27EUCTR2005-005265-11-FR
(EUCTR)
14/12/200627/10/2006A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
218Phase 3France;Czech Republic;United Kingdom
28EUCTR2005-005265-11-CZ
(EUCTR)
17/10/200624/08/2006A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
312United Kingdom;Czech Republic;France
29EUCTR2005-005265-11-GB
(EUCTR)
03/04/200624/02/2006 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 LtdNULLNot 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): noFrance;Czech Republic;United Kingdom
30EUCTR2005-002728-33-GB
(EUCTR)
28/02/200629/12/2005Cannabinoid Use in Progressive Inflammatory brain Disease - CUPIDCannabinoid Use in Progressive Inflammatory brain Disease - CUPID Progressive multiple sclerosisProduct Name: Dronabinol
INN or Proposed INN: Dronabinol
Plymouth Hospitals NHS TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
492United Kingdom
31EUCTR2004-002509-63-CZ
(EUCTR)
11/03/200504/02/2005A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/AA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
284United Kingdom;Czech Republic
32EUCTR2004-002509-63-GB
(EUCTR)
21/02/200523/02/2005A double blind, randomised, placebo controlled, parallel group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis - N/AA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
284Phase 3Czech Republic;United Kingdom
33NCT01610687
(ClinicalTrials.gov)
July 200131/5/2012A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisA 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 ExtensionMultiple Sclerosis;SpasticityDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll137Phase 3United Kingdom
34NCT01610700
(ClinicalTrials.gov)
May 200131/5/2012An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis PatientsDouble 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 ExtensionMultiple SclerosisDrug: GW-1000-02;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll160Phase 3United Kingdom
35NCT01610713
(ClinicalTrials.gov)
May 200131/5/2012An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisDouble 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 ExtensionMultiple SclerosisDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll154Phase 3United Kingdom