Sativex oromucosal spray (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 5 |
| 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 | 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;Czech Republic;Poland;Romania;United Kingdom | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | Poland;United Kingdom | ||
| 5 | 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 |