SATIVEX ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
13多発性硬化症/視神経脊髄炎39

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-022808-40-IT
(EUCTR)
13/01/201102/02/2011A fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - NDA fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - ND amyotrophic lateral sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10002026
Trade Name: sativex
INN or Proposed INN: sativex
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABORNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy

13. 多発性硬化症/視神経脊髄炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004306-58-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
2EUCTR2020-003271-18-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
3EUCTR2020-003271-18-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 3United States;Czechia;Czech Republic;Spain;Poland;United Kingdom
4EUCTR2019-002625-29-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
5EUCTR2019-002623-14-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
6EUCTR2019-002623-14-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
7EUCTR2019-002625-29-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
8EUCTR2019-002623-14-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
9EUCTR2019-002625-29-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
10NCT03186664
(ClinicalTrials.gov)
December 28, 20167/6/2017The Role of SAtivex® in Robotic-RehabilitationThe Role of SAtivex® Associated With Robotic-Rehabilitation in Improving the Motor Performances of Multiple Sclerosis Patients (SARR)RehabilitationDevice: Lokomat training;Drug: SativexIRCCS Centro Neurolesi Bonino-PulejoNULLCompleted18 Years65 YearsAll40N/AItaly
11EUCTR2015-004451-40-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
12EUCTR2015-004451-40-CZ
(EUCTR)
17/02/201622/12/2015SATIVEX® 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: SATIVEXAlmirall Hermal GmbHNULLNot RecruitingFemale: yes
Male: yes
228Phase 4Czech Republic;Austria
13NCT01868048
(ClinicalTrials.gov)
October 201330/5/2013Phase 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 SclerosisDrug: Sativex;Drug: PlaceboGW Research LtdNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
14EUCTR2011-000985-36-ES
(EUCTR)
22/02/201325/01/2012Study 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 SativexStudy 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 DOMINGUEZNULLNot RecruitingFemale: yes
Male: yes
Spain
15NCT01538225
(ClinicalTrials.gov)
April 201220/2/2012Neurophysiological Study of Sativex in Multiple Sclerosis (MS) SpasticityNeurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple SclerosisMultiple SclerosisDrug: Sativex®;Drug: PlaceboAlmirall, S.A.NULLCompleted18 YearsN/ABoth45Phase 3Italy
16NCT01964547
(ClinicalTrials.gov)
January 201215/10/2013A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis PatientsA 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 SclerosisMultiple Sclerosis;SpasticityDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll121Phase 4Czech Republic
17EUCTR2011-002258-30-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
18EUCTR2011-000926-31-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
19NCT02073474
(ClinicalTrials.gov)
February 201121/2/2014An 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 PainDrug: Sativex®Jazz PharmaceuticalsNULLCompletedN/AN/AAll978NULL
20EUCTR2006-005910-11-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
21EUCTR2006-005910-11-IT
(EUCTR)
16/04/200823/04/2008A 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. - Study of Sativex in subjects with spasticity due to MSA 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 LTDNULLNot RecruitingFemale: yes
Male: yes
488Phase 3Spain;Germany;United Kingdom;Italy
22EUCTR2006-005910-11-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
23NCT00681538
(ClinicalTrials.gov)
January 200819/5/2008A 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 SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll572Phase 3United Kingdom
24NCT00702468
(ClinicalTrials.gov)
November 200719/6/2008Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple SclerosisA 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 SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll36Phase 3United Kingdom
25EUCTR2007-002138-13-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
26EUCTR2006-005910-11-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
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
29NCT00391079
(ClinicalTrials.gov)
September 200620/10/2006Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MSA 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 SclerosisMultiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll339Phase 3Canada
30EUCTR2005-005265-11-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
31NCT00202423
(ClinicalTrials.gov)
July 200512/9/2005Use of Cannabinoids in Patients With Multiple SclerosisfMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple SclerosisMultiple SclerosisDrug: SativexS. Andrea HospitalUniversity of Roma La SapienzaRecruiting18 Years60 YearsBoth20Phase 2Italy
32EUCTR2004-002509-63-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
33NCT01599234
(ClinicalTrials.gov)
March 200510/5/2012A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple SclerosisA Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis.Multiple SclerosisDrug: Sativex;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll337Phase 3United Kingdom
34EUCTR2004-002509-63-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
35EUCTR2005-000393-47-IT
(EUCTR)
22/09/200405/03/2007Effect 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 ROMANULLNot RecruitingFemale: yes
Male: yes
Italy
36NCT00678795
(ClinicalTrials.gov)
August 200214/5/2008A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple SclerosisA 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 SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll135Phase 3United Kingdom
37NCT00711646
(ClinicalTrials.gov)
June 20028/7/2008A 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 SclerosisDrug: Sativex®;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll189Phase 3United Kingdom
38NCT01604265
(ClinicalTrials.gov)
March 200221/5/2012A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple SclerosisA Double Blind, Randomised, Parallel Group, Placebo Controlled Study of Sativex in the Treatment of Central Neuropathic Pain in Multiple Sclerosis.Multiple Sclerosis;Neuropathic PainDrug: Placebo;Drug: SativexGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll66Phase 3United Kingdom
39NCT01606137
(ClinicalTrials.gov)
February 200221/5/2012A Study of the Long-term Safety of Sativex UseA 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;PainDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll507Phase 3United Kingdom