Cbd (DrugBank: -)
11 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 |
| 6 | パーキンソン病 | 3 |
| 8 | ハンチントン病 | 1 |
| 13 | 多発性硬化症／視神経脊髄炎 | 11 |
| 46 | 悪性関節リウマチ | 2 |
| 140 | ドラベ症候群 | 13 |
| 144 | レノックス・ガストー症候群 | 15 |
| 145 | ウエスト症候群 | 3 |
| 156 | レット症候群 | 5 |
| 158 | 結節性硬化症 | 5 |
| 206 | 脆弱X症候群 | 2 |
| 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 | NCT03690791 (ClinicalTrials.gov) | January 9, 2019 | 13/9/2018 | Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease | A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: MediCabilis CBD Oil;Drug: Placebo Oil | Gold Coast Hospital and Health Service | BOD Australia | Recruiting | 25 Years | 80 Years | All | 30 | Phase 3 | Australia |
| 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 | EUCTR2019-003623-37-GB (EUCTR) | 12/02/2020 | 02/01/2020 | CANnabidiol for Parkinson’s Disease Psychosis | CANnabidiol for Parkinson’s Disease Psychosis - CAN-PDP | Parkinson's disease psychosis MedDRA version: 20.0;Level: PT;Classification code 10074835;Term: Parkinson's disease psychosis;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02] | Product Name: Cannabidiol Product Code: Cannabidiol INN or Proposed INN: Cannabidiol (CBD) | King's College London | South London and Maudsley NHS Foundation Trust | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 2 | United Kingdom | ||
| 2 | NCT03582137 (ClinicalTrials.gov) | September 17, 2018 | 17/4/2018 | A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease | Parkinson Disease | Drug: Cannabidiol;Other: Placebo | University of Colorado, Denver | Colorado Department of Public Health and Environment | Recruiting | 40 Years | 85 Years | All | 75 | Phase 2 | United States |
| 3 | NCT02818777 (ClinicalTrials.gov) | October 2016 | 6/5/2016 | A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease | Parkinson's Disease | Drug: cannabidiol | University of Colorado, Denver | Colorado Department of Public Health and Environment;GW Research Ltd | Completed | 40 Years | 80 Years | All | 13 | Phase 2 | United States |
| 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 | NCT01502046 (ClinicalTrials.gov) | September 2011 | 29/12/2011 | Neuroprotection by Cannabinoids in Huntington's Disease | A Double Blind, Randomized, Cross Over, Placebo Controlled Phase 2 Clinical Trial to Asses Neuroprotection by Cannabinoids in Huntington's Disease | Huntington's Disease | Drug: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD);Drug: Placebo | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | GW Pharmaceuticals Ltd. | Completed | 18 Years | N/A | Both | 25 | Phase 2 | Spain |
| 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-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;Czech Republic;Poland;Romania;United Kingdom | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | EUCTR2018-002315-98-DK (EUCTR) | 06/12/2018 | 09/07/2018 | The 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 Universitetshospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Denmark | ||
| 7 | 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 | ||
| 8 | 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 |
| 9 | NCT01610687 (ClinicalTrials.gov) | July 2001 | 31/5/2012 | A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | A 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 Extension | Multiple Sclerosis;Spasticity | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 137 | Phase 3 | United Kingdom |
| 10 | NCT01610700 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients | 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 Extension | Multiple Sclerosis | Drug: GW-1000-02;Drug: Placebo | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | United Kingdom |
| 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 |
| 11 | NCT01610713 (ClinicalTrials.gov) | May 2001 | 31/5/2012 | An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis | 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 Extension | Multiple Sclerosis | Drug: GW-1000-02 | GW Pharmaceuticals Ltd. | NULL | Completed | 18 Years | N/A | All | 154 | Phase 3 | United Kingdom |
| 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 | NCT04269993 (ClinicalTrials.gov) | June 1, 2020 | 12/2/2020 | Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis | Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Cannabis: placebo and medium THC/medium CBD | Brown University | NULL | Not yet recruiting | 18 Years | 65 Years | All | 76 | Phase 2 | NULL |
| 2 | EUCTR2017-004226-15-DK (EUCTR) | 26/10/2018 | 05/01/2018 | Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. | CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art | Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | King Christian 10th Hospital for Rheumatology | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Denmark |
| 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 | NCT04611438 (ClinicalTrials.gov) | March 30, 2020 | 16/9/2019 | Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome | A Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: Cannabidiol | Yonsei University | NULL | Recruiting | 2 Years | 18 Years | All | 107 | Phase 3 | Korea, Republic of |
| 2 | NCT03467113 (ClinicalTrials.gov) | January 19, 2018 | 30/1/2018 | A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBD | An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: ZX008 0.2 and 0.8 mg/kg/day | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Active, not recruiting | 2 Years | 18 Years | All | 25 | Phase 1;Phase 2 | United States |
| 3 | NCT02815540 (ClinicalTrials.gov) | February 16, 2017 | 20/6/2016 | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children | Lennox-Gastaut Syndrome;Dravet Syndrome | Procedure: 12-Lead ECG;Drug: Cannabidiol | Gillette Children's Specialty Healthcare | NULL | Terminated | 2 Years | 30 Years | All | 2 | Phase 1;Phase 2 | United States |
| 4 | EUCTR2014-001834-27-NL (EUCTR) | 09/09/2015 | 18/06/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 5 | EUCTR2014-001834-27-FR (EUCTR) | 03/09/2015 | 20/07/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 530 | Phase 3 | United States;France;Spain;Poland;Israel;Netherlands;United Kingdom | ||
| 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 |
| 6 | EUCTR2014-001834-27-PL (EUCTR) | 18/08/2015 | 14/05/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 7 | NCT02224573 (ClinicalTrials.gov) | June 2015 | 21/8/2014 | GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes | An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes. | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: GWP42003-P | GW Research Ltd | NULL | Completed | 2 Years | N/A | All | 681 | Phase 3 | NULL |
| 8 | EUCTR2014-001834-27-ES (EUCTR) | 21/05/2015 | 14/04/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 430 | Phase 3 | France;United States;Poland;Spain;Israel;Netherlands;United Kingdom | |||
| 9 | EUCTR2014-002939-34-ES (EUCTR) | 08/04/2015 | 16/12/2014 | A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet syndrome MedDRA version: 17.1;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Poland;Spain;Israel;Netherlands;United Kingdom | ||
| 10 | EUCTR2014-000995-24-PL (EUCTR) | 09/03/2015 | 31/10/2014 | A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet Syndrome MedDRA version: 18.1;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 125 | France;United States;Poland;United Kingdom | |||
| 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 |
| 11 | EUCTR2014-002939-34-NL (EUCTR) | 04/03/2015 | 16/03/2015 | A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet syndrome MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom | ||
| 12 | EUCTR2014-001834-27-GB (EUCTR) | 14/01/2015 | 30/09/2014 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 680 | Phase 3 | France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom | ||
| 13 | EUCTR2014-002939-34-PL (EUCTR) | 25/01/2016 | A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome. | Dravet syndrome MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | United States;Spain;Poland;Australia;Israel;Netherlands;United Kingdom |
| 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 | NCT04611438 (ClinicalTrials.gov) | March 30, 2020 | 16/9/2019 | Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome | A Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: Cannabidiol | Yonsei University | NULL | Recruiting | 2 Years | 18 Years | All | 107 | Phase 3 | Korea, Republic of |
| 2 | NCT03467113 (ClinicalTrials.gov) | January 19, 2018 | 30/1/2018 | A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBD | An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | Dravet Syndrome;Lennox Gastaut Syndrome | Drug: ZX008 0.2 and 0.8 mg/kg/day | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | NULL | Active, not recruiting | 2 Years | 18 Years | All | 25 | Phase 1;Phase 2 | United States |
| 3 | NCT02815540 (ClinicalTrials.gov) | February 16, 2017 | 20/6/2016 | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy | The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children | Lennox-Gastaut Syndrome;Dravet Syndrome | Procedure: 12-Lead ECG;Drug: Cannabidiol | Gillette Children's Specialty Healthcare | NULL | Terminated | 2 Years | 30 Years | All | 2 | Phase 1;Phase 2 | United States |
| 4 | EUCTR2014-002941-23-NL (EUCTR) | 30/09/2015 | 31/03/2015 | Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adults | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox- Gastaut syndrome in children and adults | Lennox-Gastaut syndrome MedDRA version: 19.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Poland;Netherlands | |||
| 5 | EUCTR2014-001834-27-NL (EUCTR) | 09/09/2015 | 18/06/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 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 |
| 6 | EUCTR2014-001834-27-FR (EUCTR) | 03/09/2015 | 20/07/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 530 | Phase 3 | United States;France;Spain;Poland;Israel;Netherlands;United Kingdom | ||
| 7 | EUCTR2014-001834-27-PL (EUCTR) | 18/08/2015 | 14/05/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom | ||
| 8 | EUCTR2014-002940-42-GB (EUCTR) | 28/07/2015 | 26/09/2014 | A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults. | Lennox-Gastaut syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;United States;Spain;United Kingdom | ||
| 9 | EUCTR2014-002941-23-PL (EUCTR) | 16/07/2015 | 01/04/2015 | Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adults | A randomized, double-blind, placebo-controlled study toinvestigate the efficacy and safety of cannabidiol (GWP42003-P;CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults | Lennox-Gastaut syndrome MedDRA version: 18.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Poland;Netherlands | ||
| 10 | NCT02224560 (ClinicalTrials.gov) | June 8, 2015 | 21/8/2014 | Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults. | Epilepsy;Lennox Gastaut Syndrome | Drug: GWP42003-P;Drug: Placebo control | GW Research Ltd | NULL | Completed | 2 Years | 55 Years | All | 225 | Phase 3 | United States;France;Spain;United Kingdom |
| 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 |
| 11 | NCT02224573 (ClinicalTrials.gov) | June 2015 | 21/8/2014 | GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes | An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes. | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: GWP42003-P | GW Research Ltd | NULL | Completed | 2 Years | N/A | All | 681 | Phase 3 | NULL |
| 12 | EUCTR2014-001834-27-ES (EUCTR) | 21/05/2015 | 14/04/2015 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 18.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 430 | Phase 3 | France;United States;Poland;Spain;Israel;Netherlands;United Kingdom | |||
| 13 | NCT02224690 (ClinicalTrials.gov) | April 28, 2015 | 21/8/2014 | A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults. | Epilepsy;Lennox-Gastaut Syndrome | Drug: GWP42003-P 20 mg/kg/day Dose;Drug: Placebo | GW Research Ltd | NULL | Completed | 2 Years | 55 Years | All | 171 | Phase 3 | United States;Netherlands;Poland |
| 14 | EUCTR2014-002940-42-ES (EUCTR) | 08/04/2015 | 16/12/2014 | A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults | A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults. | Lennox-Gastaut syndrome (LGS) MedDRA version: 17.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;United Kingdom | ||
| 15 | EUCTR2014-001834-27-GB (EUCTR) | 14/01/2015 | 30/09/2014 | An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut Syndromes | An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes | Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: PT;Classification code 10073677;Term: Severe myoclonic epilepsy of infancy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 680 | Phase 3 | France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom |
| 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 | NCT02954887 (ClinicalTrials.gov) | May 12, 2017 | 2/11/2016 | Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) | A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study | Infantile Spasms | Drug: GWP42003-P | GW Research Ltd | NULL | Completed | 1 Month | 24 Months | All | 9 | Phase 3 | United States;Poland |
| 2 | NCT02953548 (ClinicalTrials.gov) | April 24, 2017 | 1/11/2016 | Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) | A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study | Infantile Spasms | Drug: GWP42003-P | GW Research Ltd | NULL | Completed | 1 Month | 24 Months | All | 9 | Phase 3 | United States;Poland |
| 3 | EUCTR2015-004904-50-PL (EUCTR) | 04/04/2017 | Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms | A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study. | Infantile Spasms MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GW Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 3 | United States;Hungary;Poland;Italy;United Kingdom |
| 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 | EUCTR2019-001605-24-ES (EUCTR) | 04/03/2020 | 21/02/2020 | An open label extension study for long-term safety of GWP42003-P in patients with Rett Syndrome | An open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome | Rett syndrome (RTT) [typical or atypical] MedDRA version: 20.0;Level: PT;Classification code 10077709;Term: Rett syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GW Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 252 | Phase 3 | United States;Canada;Spain;Australia;Italy;United Kingdom | |||
| 2 | NCT04252586 (ClinicalTrials.gov) | February 28, 2020 | 30/1/2020 | An Open-label Extension Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome | An Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome | Rett Syndrome;RTT | Drug: GWP42003-P | GW Research Ltd | NULL | Enrolling by invitation | 2 Years | 18 Years | All | 252 | Phase 3 | United States;Australia;Canada;Italy;Spain;United Kingdom |
| 3 | EUCTR2019-001605-24-GB (EUCTR) | 15/01/2020 | 23/10/2019 | An open label extension study for long-term safety of GWP42003-P in patients with Rett Syndrome | An open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome | Rett syndrome (RTT) [typical or atypical] MedDRA version: 20.0;Level: PT;Classification code 10077709;Term: Rett syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD Oral solution, is known as Epidyolex and is the approved name in the EU Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: Cannabidiol Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 3 | United States;France;Canada;Spain;Australia;Italy;United Kingdom | ||
| 4 | NCT03848832 (ClinicalTrials.gov) | July 29, 2019 | 19/2/2019 | Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome | A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome | Rett Syndrome;RTT | Drug: GWP42003-P;Drug: Placebo | GW Research Ltd | NULL | Active, not recruiting | 2 Years | 18 Years | Female | 252 | Phase 3 | United States;Italy;Spain;United Kingdom |
| 5 | EUCTR2018-003370-27-GB (EUCTR) | 09/04/2019 | 24/12/2018 | A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome. | A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome. | Rett syndrome (RTT) [typical or atypical] MedDRA version: 20.0;Level: PT;Classification code 10077709;Term: Rett syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CBD - Oral Solution, is known as Epidyolex, and is the approved name Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: Cannabidiol Other descriptive name: CANNABIDIOL | GW Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2;Phase 3 | United States;France;Canada;Spain;Australia;Italy;United Kingdom |
| 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 | EUCTR2015-002154-12-NL (EUCTR) | 01/09/2017 | 17/01/2017 | A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures. | A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures | Tuberous Sclerosis Complex (TSC) MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | GW Research Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Poland;Spain;Australia;Netherlands;United Kingdom | |||
| 2 | EUCTR2015-002154-12-ES (EUCTR) | 30/09/2016 | 15/07/2016 | A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures. | A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures | Tuberous Sclerosis Complex (TSC) MedDRA version: 19.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | France;United States;Spain;Australia;United Kingdom | ||
| 3 | NCT02544750 (ClinicalTrials.gov) | August 2016 | 7/9/2015 | An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) | A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures | Tuberous Sclerosis Complex;Seizures | Drug: GWP42003-P | GW Research Ltd | NULL | Enrolling by invitation | 1 Year | 65 Years | All | 210 | Phase 3 | United States |
| 4 | NCT02544763 (ClinicalTrials.gov) | April 6, 2016 | 7/9/2015 | A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) | A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures | Tuberous Sclerosis Complex;Seizures | Drug: GWP42003-P;Drug: Placebo | GW Research Ltd | NULL | Completed | 1 Year | 65 Years | All | 224 | Phase 3 | United States;Australia;Netherlands;Poland;Spain;United Kingdom |
| 5 | EUCTR2015-002154-12-PL (EUCTR) | 18/11/2016 | A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures. | A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures | Tuberous Sclerosis Complex (TSC) MedDRA version: 21.0;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA. Product Name: Cannabidiol (CBD) Product Code: GWP42003-P INN or Proposed INN: N/A Other descriptive name: CANNABIDIOL | GW Research Ltd. | NULL | NA | Female: yes Male: yes | 210 | Phase 3 | United States;Spain;Poland;Australia;Netherlands;United Kingdom |
| 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 | NCT03802799 (ClinicalTrials.gov) | November 9, 2018 | 26/12/2018 | Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS | An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome - CONNECT-FX Open Label Extension (OLE) | Fragile X Syndrome | Drug: ZYN002 - CBD Transdermal Gel | Zynerba Pharmaceuticals, Inc. | NULL | Recruiting | 3 Years | 18 Years | All | 300 | Phase 2;Phase 3 | United States;Australia;New Zealand |
| 2 | NCT03614663 (ClinicalTrials.gov) | June 12, 2018 | 10/7/2018 | Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX) | A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome | Fragile X Syndrome | Drug: ZYN002 - CBD Transdermal Gel;Other: Placebo Transdermal Gel | Zynerba Pharmaceuticals, Inc. | NULL | Completed | 3 Years | 17 Years | All | 212 | Phase 2;Phase 3 | United States;Australia;New Zealand |