Nabiximols - Sativex ( DrugBank: Nabiximols )


1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica5

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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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
5EUCTR2019-002625-29-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