Cannabidiol ( DrugBank: Cannabidiol )


18 diseases
告示番号疾患名(ページ内リンク)臨床試験数
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27
36表皮水疱症2
46悪性関節リウマチ2
95自己免疫性肝炎1
96クローン病3
97潰瘍性大腸炎3
140ドラベ症候群20
144レノックス・ガストー症候群18
145ウエスト症候群4
156レット症候群7
157スタージ・ウェーバー症候群2
158結節性硬化症8
193プラダー・ウィリ症候群3
206脆弱X症候群3
226間質性膀胱炎(ハンナ型)1
271強直性脊椎炎1

6. パーキンソン病


臨床試験数 : 2,298 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003623-37-GB
(EUCTR)
12/02/202002/01/2020CANnabidiol for Parkinson’s Disease PsychosisCANnabidiol 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 LondonSouth London and Maudsley NHS Foundation TrustAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United Kingdom
2NCT03582137
(ClinicalTrials.gov)
September 17, 201817/4/2018A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's DiseaseParkinson DiseaseDrug: Cannabidiol;Other: PlaceboUniversity of Colorado, DenverColorado Department of Public Health and EnvironmentCompleted40 Years85 YearsAll74Phase 2United States
3NCT02818777
(ClinicalTrials.gov)
October 20166/5/2016A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's DiseaseParkinson's DiseaseDrug: cannabidiolUniversity of Colorado, DenverColorado Department of Public Health and Environment;GW Research LtdCompleted40 Years80 YearsAll13Phase 2United States

8. ハンチントン病


臨床試験数 : 229 薬物数 : 193 - (DrugBank : 60) / 標的遺伝子数 : 84 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01502046
(ClinicalTrials.gov)
September 201129/12/2011Neuroprotection by Cannabinoids in Huntington's DiseaseA Double Blind, Randomized, Cross Over, Placebo Controlled Phase 2 Clinical Trial to Asses Neuroprotection by Cannabinoids in Huntington's DiseaseHuntington's DiseaseDrug: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD);Drug: PlaceboFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalGW Pharmaceuticals Ltd.Completed18 YearsN/ABoth25Phase 2Spain

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05269628
(ClinicalTrials.gov)
March 202213/2/2022Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain PhenotypeMechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain PhenotypeMultiple Sclerosis;Sleep;PainDrug: Cannabidiol (CBD);Drug: Tetrahydrocannabinol (THC);Drug: Placebo CBD;Drug: Placebo THCTiffany J. Braley, MD, MSNational Center for Complementary and Integrative Health (NCCIH)Not yet recruiting18 Years65 YearsAll166Phase 2United States
2EUCTR2020-004306-58-LT
(EUCTR)
28/01/202225/11/2021A study to asses the effects of Nabiximols on spasticity associated with multiple sclerosis.A randomized double-blind placebo-controlled study of nabiximols in patients with spasticity in multiple sclerosis - RELEASE MSS4 Symptomatic treatment of spasticity in patients with MS
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Nabiximols - Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 3United States;Hungary;Canada;Spain;Lithuania;Bulgaria;United Kingdom;Italy
3EUCTR2020-003271-18-ES
(EUCTR)
01/07/202105/07/2021A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex 2,7mg/2,5 mg Solucion para pulverizacion bucal
Product Name: Nabiximols - Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3Czechia;Czech Republic;Poland;Belgium;Spain;Australia;United Kingdom;Sweden
4EUCTR2020-003271-18-CZ
(EUCTR)
07/06/202107/04/2021A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray
Product Name: Nabiximols - Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3Czechia;Czech Republic;Spain;Poland;Belgium;Australia;United Kingdom;Sweden
5EUCTR2019-002625-29-CZ
(EUCTR)
18/05/202110/03/2021A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray
Product Name: Nabiximols - Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLNot RecruitingFemale: yes
Male: yes
104Phase 3Czechia;Czech Republic;Poland;United Kingdom
6EUCTR2019-002623-14-PL
(EUCTR)
15/04/202021/01/2020A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis Symptomatic relief of spasticity in Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czechia;Czech Republic;Poland;Romania;United Kingdom
7EUCTR2019-002623-14-CZ
(EUCTR)
17/03/202019/12/2019A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis Symptomatic relief of spasticity in Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray (non-marketed)
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czechia;Czech Republic;Poland;Romania;United Kingdom
8EUCTR2019-002625-29-GB
(EUCTR)
16/03/202018/06/2020A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis - Study in MS patient Naïve to treatment with Nabiximols Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray
Product Name: Sativex Oromucosal Spray
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 3Poland;United Kingdom
9EUCTR2019-002623-14-GB
(EUCTR)
24/02/202018/03/2020A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis - Nabiximols Oromucosal Spray as Add-on Therapy in Patients with MS Symptomatic relief of spasticity in Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: UK: Sativex Oromucosal Spray
Product Name: UK: Sativex Oromucosal Spray
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czech Republic;Poland;Romania;United Kingdom
10EUCTR2019-002625-29-PL
(EUCTR)
14/01/202021/11/2019A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray
Product Name: Nabiximols - Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 3Czechia;Czech Republic;Poland;United Kingdom
11EUCTR2018-002315-98-DK
(EUCTR)
06/12/201809/07/2018The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury.The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI Central neuropathic pain and spasticity
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol capsule 5 mg
Product Code: N/A
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Product Name: Dronabinol capsule 2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Aarhus UniversitetshospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2Denmark
12EUCTR2015-004451-40-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
13EUCTR2011-000985-36-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
14EUCTR2011-002258-30-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
15EUCTR2011-000926-31-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
16EUCTR2006-005910-11-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
17EUCTR2006-005910-11-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
18EUCTR2007-002138-13-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
19EUCTR2006-005910-11-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
20EUCTR2005-005265-11-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
21EUCTR2005-005265-11-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
22EUCTR2005-005265-11-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
23EUCTR2004-002509-63-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
24EUCTR2004-002509-63-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
25NCT01610687
(ClinicalTrials.gov)
July 200131/5/2012A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisA Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple Sclerosis;SpasticityDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll137Phase 3United Kingdom
26NCT01610713
(ClinicalTrials.gov)
May 200131/5/2012An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple SclerosisDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02GW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll154Phase 3United Kingdom
27NCT01610700
(ClinicalTrials.gov)
May 200131/5/2012An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis PatientsDouble Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study ExtensionMultiple SclerosisDrug: GW-1000-02;Drug: PlaceboGW Pharmaceuticals Ltd.NULLCompleted18 YearsN/AAll160Phase 3United Kingdom

36. 表皮水疱症


臨床試験数 : 160 薬物数 : 195 - (DrugBank : 47) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 124
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04613102
(ClinicalTrials.gov)
August 1, 202027/10/2020The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III TrialThe Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III TrialEpidermolysis Bullosa;Pain;ItchDrug: AVCN583601 (3% Cannabidiol cream)Elena PopeAvicanna IncWithdrawn4 Years50 YearsAll0Phase 2/Phase 3Canada
2EUCTR2021-000103-20-NL
(EUCTR)
15/07/2021A study on the effect of Transvamix on pain in adults with epidermolysis bullosa.An explorative randomized, placebo-controlled and double-blind intervention crossover study: Transvamix (100mg/mL THC / 50mg/mL CBD) to treat chronic pain in Epidermolysis Bullosa Genetic Epidermolysis Bullosa;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Transvamix (100mg/mL THC, 50mg/mL CBD)
INN or Proposed INN: THC
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: CBD
Other descriptive name: CANNABIDIOL
University Medical Center GroningenNULLNAFemale: yes
Male: yes
16Phase 2Netherlands

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04911127
(ClinicalTrials.gov)
October 5, 202114/5/2021Therapeutic Response of Cannabidiol in Rheumatoid ArthritisRandomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid ArthritisRheumatoid Arthritis;CannabisDrug: 200mg Cannabidiol by capsules twice daily;Drug: 400mg Cannabidiol by capsules twice daily;Drug: Placebo capsulesUniversity of California, Los AngelesNULLRecruiting18 YearsN/AAll60Phase 1/Phase 2United States
2EUCTR2017-004226-15-DK
(EUCTR)
26/10/201805/01/2018 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]
Product Name: Cannabidiol tablet 10 mg
Other descriptive name: CANNABIDIOL
Product Name: Dronabinol capsule 2.5. mg
INN or Proposed INN: DRONABINOL
King Christian 10th Hospital for RheumatologyNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark

95. 自己免疫性肝炎


臨床試験数 : 52 薬物数 : 68 - (DrugBank : 28) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 112
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04129489
(ClinicalTrials.gov)
February 7, 201918/3/2019A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune HepatitisA Phase 2a Open Label, Single Arm Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune HepatitisAutoimmune HepatitisDrug: CannabidiolStero Biotechs Ltd.NULLTerminated18 YearsN/AAll2Phase 2Israel

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04056442
(ClinicalTrials.gov)
July 7, 201913/8/2019A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease PatientsA Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease PatientsSteroid Dependent Crohn's DiseaseDrug: Cannabidiol , synthetic form;Drug: PlaceboStero Biotechs Ltd.NULLRecruiting18 YearsN/AAll28Phase 2Israel
2NCT03467620
(ClinicalTrials.gov)
July 20185/3/2018Cannabidiol Usage as an Adjunct Therapy for Crohn's DiseaseOral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled StudyCrohn Disease;Inflammatory Bowel Diseases;CannabisDrug: Cannabidiol;Drug: Placebo oral capsuleUniversity of Illinois at ChicagoNULLWithdrawn18 YearsN/AAll0Phase 2/Phase 3NULL
3NCT01037322
(ClinicalTrials.gov)
January 201020/12/2009Cannabidiol for Inflammatory Bowel DiseaseUse of Cannabidiol for the Treatment of Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative ColitisDrug: cannabidiol;Drug: placebo in dropsMeir Medical CenterNULLCompleted20 Years80 YearsBoth20Phase 1/Phase 2Israel

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-003208-19-CZ
(EUCTR)
05/09/201303/04/2013GWP42003 symptomatic treatment of ulcerative colitis.A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis. Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GWP42003
INN or Proposed INN: Not Applicable
Other descriptive name: CANNABIDIOL
GW Pharma Ltd.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2Czech Republic;United Kingdom
2EUCTR2011-003208-19-GB
(EUCTR)
16/11/201128/09/2011GWP42003 symptomatic treatment of ulcerative colitis.A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis. Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GWP42003
INN or Proposed INN: Not applicable
Other descriptive name: CANNABIDIOL
GW Pharma Ltd.NULLNot Recruiting Female: yes
Male: yes
62 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;United Kingdom
3NCT01037322
(ClinicalTrials.gov)
January 201020/12/2009Cannabidiol for Inflammatory Bowel DiseaseUse of Cannabidiol for the Treatment of Inflammatory Bowel DiseaseCrohn's Disease;Ulcerative ColitisDrug: cannabidiol;Drug: placebo in dropsMeir Medical CenterNULLCompleted20 Years80 YearsBoth20Phase 1/Phase 2Israel

140. ドラベ症候群


臨床試験数 : 104 薬物数 : 61 - (DrugBank : 14) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 63
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05044819
(ClinicalTrials.gov)
July 7, 202130/8/2021Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionA Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionLennox Gastaut Syndrome;Dravet Syndrome;Tuberous Sclerosis ComplexDrug: CannabidiolGW Research LtdNULLRecruiting1 YearN/AAll150Phase 4United States
2NCT04611438
(ClinicalTrials.gov)
March 30, 202016/9/2019Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut SyndromeA Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: CannabidiolYonsei UniversityNULLRecruiting2 Years18 YearsAll107Phase 3Korea, Republic of
3NCT03467113
(ClinicalTrials.gov)
January 19, 201830/1/2018A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking CannabidiolAn 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 SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: ZX008 0.2 to 0.8 mg/kg/day;Drug: CannabidiolZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLCompleted2 Years18 YearsAll9Phase 1/Phase 2United States
4NCT02318563
(ClinicalTrials.gov)
December 30, 201712/12/2014Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet SyndromeA Multicenter, Randomized, Double-blind, Placebo- Controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Dravet SyndromeDravet SyndromeDrug: Cannabidiol Oral Solution;Drug: Placebo SolutionINSYS Therapeutics IncNULLWithdrawn1 Year30 YearsAll0Phase 3NULL
5NCT02815540
(ClinicalTrials.gov)
February 16, 201720/6/2016The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe EpilepsyThe Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in ChildrenLennox-Gastaut Syndrome;Dravet SyndromeProcedure: 12-Lead ECG;Drug: CannabidiolGillette Children's Specialty HealthcareNULLTerminated2 Years30 YearsAll2Phase 1/Phase 2United States
6EUCTR2014-001834-27-NL
(EUCTR)
09/09/201518/06/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
7EUCTR2014-001834-27-FR
(EUCTR)
03/09/201520/07/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
8EUCTR2014-001834-27-PL
(EUCTR)
18/08/201514/05/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
9NCT02224573
(ClinicalTrials.gov)
June 201521/8/2014GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut SyndromesAn 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 SyndromeDrug: GWP42003-PGW Research LtdNULLCompleted2 YearsN/AAll681Phase 3NULL
10EUCTR2014-001834-27-ES
(EUCTR)
21/05/201514/04/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot Recruiting Female: yes
Male: yes
430 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Israel;Netherlands;United Kingdom
11NCT02224703
(ClinicalTrials.gov)
April 13, 201521/8/2014GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet SyndromeA Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome.Epilepsy;Dravet SyndromeDrug: GWP42003-P;Drug: Placebo ControlGW Research LtdNULLCompleted2 Years18 YearsAll199Phase 3United States;Australia;Israel;Netherlands;Poland;Spain
12EUCTR2014-002939-34-ES
(EUCTR)
08/04/201516/12/2014A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Poland;Spain;Israel;Netherlands;United Kingdom
13NCT02091375
(ClinicalTrials.gov)
March 30, 201517/3/2014Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)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 SyndromeEpilepsy;Dravet SyndromeDrug: GWP42003-P 20 mg/kg/day Dose;Drug: Placebo controlGW Research LtdNULLCompleted2 Years18 YearsAll120Phase 3United States;France;Poland;United Kingdom
14EUCTR2014-000995-24-PL
(EUCTR)
09/03/201531/10/2014A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
125France;United States;Poland;United Kingdom
15EUCTR2014-002939-34-NL
(EUCTR)
04/03/201516/03/2015A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
16EUCTR2014-001834-27-GB
(EUCTR)
14/01/201530/09/2014An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
680Phase 3France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom
17EUCTR2014-002939-34-GB
(EUCTR)
29/12/201424/09/2014A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 17.0;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 LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Spain;Israel;Netherlands;United Kingdom
18NCT02091206
(ClinicalTrials.gov)
October 22, 201417/3/2014A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)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 SyndromeEpilepsy;Dravet SyndromeDrug: GWP42003-P 5 mg/kg/day Dose;Drug: Placebo control;Drug: GWP42003-P 10 mg/kg/day Dose;Drug: GWP42003-P 20 mg/kg/day DoseGW Research LtdNULLCompleted4 Years10 YearsAll34Phase 2United States;United Kingdom
19EUCTR2014-000995-24-GB
(EUCTR)
09/09/201404/07/2014A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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: 18.0;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
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;United Kingdom
20EUCTR2014-002939-34-PL
(EUCTR)
25/01/2016A study of the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
186Phase 3United States;Spain;Poland;Australia;Israel;Netherlands;United Kingdom

144. レノックス・ガストー症候群


臨床試験数 : 101 薬物数 : 68 - (DrugBank : 12) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 60
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05044819
(ClinicalTrials.gov)
July 7, 202130/8/2021Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionA Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionLennox Gastaut Syndrome;Dravet Syndrome;Tuberous Sclerosis ComplexDrug: CannabidiolGW Research LtdNULLRecruiting1 YearN/AAll150Phase 4United States
2NCT04133480
(ClinicalTrials.gov)
October 202017/10/2019Investigation of Cognitive Outcomes With Cannabidiol Oral SolutionAn Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P)Lennox-Gastaut SyndromeDrug: GWP42003-PGW Research LtdNULLWithdrawn3 Years10 YearsAll0Phase 4United States
3NCT04611438
(ClinicalTrials.gov)
March 30, 202016/9/2019Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut SyndromeA Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: CannabidiolYonsei UniversityNULLRecruiting2 Years18 YearsAll107Phase 3Korea, Republic of
4NCT03467113
(ClinicalTrials.gov)
January 19, 201830/1/2018A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking CannabidiolAn 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 SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: ZX008 0.2 to 0.8 mg/kg/day;Drug: CannabidiolZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLCompleted2 Years18 YearsAll9Phase 1/Phase 2United States
5NCT02318537
(ClinicalTrials.gov)
December 30, 201712/12/2014Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-blind, Placebo-controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: Cannabidiol Oral Solution;Drug: Placebo SolutionINSYS Therapeutics IncNULLWithdrawn2 Years30 YearsAll0Phase 3NULL
6NCT02815540
(ClinicalTrials.gov)
February 16, 201720/6/2016The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe EpilepsyThe Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in ChildrenLennox-Gastaut Syndrome;Dravet SyndromeProcedure: 12-Lead ECG;Drug: CannabidiolGillette Children's Specialty HealthcareNULLTerminated2 Years30 YearsAll2Phase 1/Phase 2United States
7EUCTR2014-002941-23-NL
(EUCTR)
30/09/201531/03/2015Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adultsA 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.NULLNot RecruitingFemale: yes
Male: yes
100United States;Poland;Netherlands
8EUCTR2014-001834-27-NL
(EUCTR)
09/09/201518/06/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
9EUCTR2014-001834-27-FR
(EUCTR)
03/09/201520/07/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
530Phase 3United States;France;Spain;Poland;Israel;Netherlands;United Kingdom
10EUCTR2014-001834-27-PL
(EUCTR)
18/08/201514/05/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;France;Spain;Poland;Australia;Israel;Netherlands;United Kingdom
11EUCTR2014-002940-42-GB
(EUCTR)
28/07/201526/09/2014A 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 AdultsA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Spain;United Kingdom
12EUCTR2014-002941-23-PL
(EUCTR)
16/07/201501/04/2015Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures associated with Lennox-Gastaut Syndrome in children and adultsA 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Poland;Netherlands
13NCT02224560
(ClinicalTrials.gov)
June 8, 201521/8/2014Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and AdultsA 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 SyndromeDrug: GWP42003-P;Drug: Placebo controlGW Research LtdNULLCompleted2 Years55 YearsAll225Phase 3United States;France;Spain;United Kingdom
14NCT02224573
(ClinicalTrials.gov)
June 201521/8/2014GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut SyndromesAn 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 SyndromeDrug: GWP42003-PGW Research LtdNULLCompleted2 YearsN/AAll681Phase 3NULL
15EUCTR2014-001834-27-ES
(EUCTR)
21/05/201514/04/2015An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLNot Recruiting Female: yes
Male: yes
430 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Israel;Netherlands;United Kingdom
16NCT02224690
(ClinicalTrials.gov)
April 28, 201521/8/2014A 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 AdultsA 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 SyndromeDrug: GWP42003-P 20 mg/kg/day Dose;Drug: PlaceboGW Research LtdNULLCompleted2 Years55 YearsAll171Phase 3United States;Netherlands;Poland
17EUCTR2014-002940-42-ES
(EUCTR)
08/04/201516/12/2014A 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 AdultsA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;United Kingdom
18EUCTR2014-001834-27-GB
(EUCTR)
14/01/201530/09/2014An open label study of the safety of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut SyndromesAn 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
680Phase 3France;United States;Poland;Spain;Australia;Israel;Netherlands;United Kingdom

145. ウエスト症候群


臨床試験数 : 43 薬物数 : 54 - (DrugBank : 15) / 標的遺伝子数 : 27 - 標的パスウェイ数 : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03421496
(ClinicalTrials.gov)
September 5, 201826/1/2018A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile SpasmsA Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile SpasmsInfantile SpasmDrug: Cannabidiol Oral Solution;Drug: Placebo;Drug: VigabatrinBenuvia Therapeutics Inc.NULLTerminated1 Month24 MonthsAll2Phase 3United States
2NCT02954887
(ClinicalTrials.gov)
May 12, 20172/11/2016Phase 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 StudyInfantile SpasmsDrug: GWP42003-PGW Research LtdNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
3NCT02953548
(ClinicalTrials.gov)
April 24, 20171/11/2016Trial 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 StudyInfantile SpasmsDrug: GWP42003-PGW Research LtdNULLCompleted1 Month24 MonthsAll9Phase 3United States;Poland
4EUCTR2015-004904-50-PL
(EUCTR)
04/04/2017Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile SpasmsA 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]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: Cannabidiol
Other descriptive name: CANNABIDIOL
GW Research LtdNULLNot Recruiting Female: yes
Male: yes
202 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Poland;Italy;United Kingdom

156. レット症候群


臨床試験数 : 40 薬物数 : 53 - (DrugBank : 19) / 標的遺伝子数 : 77 - 標的パスウェイ数 : 113
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001605-24-IT
(EUCTR)
02/11/202021/01/2021An open label extension study for long-term safety of GWP42003-P in patients with Rett SyndromeAn open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome - NA 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 soluzione orale nota come Epidyolex e con tale nome è stato approvato in UE
Product Name: Cannabidiolo
Product Code: [GWP42003-P]
INN or Proposed INN: cannabidiolo
Other descriptive name: cannabidiol
GW RESEARCH LTD.NULLNAFemale: yes
Male: no
252Phase 3United States;Canada;Spain;Australia;United Kingdom;Italy
2EUCTR2019-001605-24-ES
(EUCTR)
04/03/202021/02/2020An open label extension study for long-term safety of GWP42003-P in patients with Rett SyndromeAn 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: 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 LtdNULLNot RecruitingFemale: yes
Male: no
252Phase 3United States;Canada;Spain;Australia;United Kingdom;Italy
3NCT04252586
(ClinicalTrials.gov)
February 28, 202030/1/2020An Open-label Extension Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeAn Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeRett Syndrome;RTTDrug: GWP42003-PGW Research LtdNULLTerminated2 Years18 YearsAll21Phase 3United States;Australia;Canada;Italy;Spain;United Kingdom
4EUCTR2019-001605-24-GB
(EUCTR)
15/01/202023/10/2019An open label extension study for long-term safety of GWP42003-P in patients with Rett SyndromeAn 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 3United States;France;Canada;Spain;Australia;Italy;United Kingdom
5EUCTR2018-003370-27-IT
(EUCTR)
18/09/201924/05/2021A 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. - Not applicable 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 - Solution Orale, conosciuto come Epidiolex, questo è il nome approvato negli Stati Uniti
Product Name: Cannabidiolo (CBD)
Product Code: [GWP42003-P]
INN or Proposed INN: Cannabidiolo
Other descriptive name: Cannabidiol
GW RESEARCH LTD.NULLNot RecruitingFemale: yes
Male: no
252Phase 3United States;Canada;Spain;Germany;United Kingdom;Italy
6NCT03848832
(ClinicalTrials.gov)
July 29, 201919/2/2019Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeA Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett SyndromeRett Syndrome;RTTDrug: GWP42003-P;Drug: PlaceboGW Research LtdNULLTerminated2 Years18 YearsFemale252Phase 3United States;Italy;Spain;United Kingdom
7EUCTR2018-003370-27-GB
(EUCTR)
09/04/201924/12/2018A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2;Phase 3United States;France;Canada;Spain;Australia;Italy;United Kingdom

157. スタージ・ウェーバー症候群


臨床試験数 : 10 薬物数 : 14 - (DrugBank : 4) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 63
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04447846
(ClinicalTrials.gov)
October 14, 201910/10/2019Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber SyndromeNovel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome: A Phase II TrialSturge-Weber SyndromeDrug: CannabidiolAnne Comi, MDJazz Pharmaceuticals;Faneca 66 FoundationCompleted3 Years50 YearsAll10Phase 2United States
2NCT02332655
(ClinicalTrials.gov)
December 20145/1/2015Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber SyndromeCannabidiol Expanded Access Study in Medically Refractory Sturge-Weber SyndromeSturge-Weber SyndromeDrug: CannabidiolAnne Comi, MDGW Pharmaceuticals Ltd.;Faneca 66 FoundationActive, not recruiting1 Month45 YearsAll5Phase 1/Phase 2United States

158. 結節性硬化症


臨床試験数 : 108 薬物数 : 67 - (DrugBank : 17) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05044819
(ClinicalTrials.gov)
July 7, 202130/8/2021Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionA Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionLennox Gastaut Syndrome;Dravet Syndrome;Tuberous Sclerosis ComplexDrug: CannabidiolGW Research LtdNULLRecruiting1 YearN/AAll150Phase 4United States
2NCT04485104
(ClinicalTrials.gov)
May 19, 202121/7/2020Safety, Pharmacokinetics, and Exploratory Efficacy Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiseizure Medication, in Participants Age 1 Month to <12 Months of Age With Tuberous Sclerosis Complex Who Experience Inadequately-controlled SeizuresAn Open-label, Randomized Trial to Assess the Safety, Pharmacokinetics, and Exploratory Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiseizure Medication, in Patients Age 1 Month to Less Than 12 Months of Age With Tuberous Sclerosis Complex Who Experience Inadequately-controlled SeizuresSeizure in Participants With Tuberous Sclerosis ComplexDrug: GWP42003-P;Drug: SOCGW Research LtdNULLRecruiting1 Month11 MonthsAll12Phase 3United States
3EUCTR2015-002154-12-NL
(EUCTR)
01/09/201717/01/2017A 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]
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.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Spain;Poland;Australia;Netherlands;United Kingdom
4EUCTR2015-002154-12-ES
(EUCTR)
30/09/201615/07/2016A 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.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;France;Poland;Spain;Australia;Netherlands;United Kingdom
5NCT02544750
(ClinicalTrials.gov)
August 20167/9/2015An 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 SeizuresTuberous Sclerosis Complex;SeizuresDrug: GWP42003-PGW Research LtdNULLCompleted1 Year65 YearsAll224Phase 3United States
6NCT02544763
(ClinicalTrials.gov)
April 6, 20167/9/2015A 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 SeizuresTuberous Sclerosis Complex;SeizuresDrug: GWP42003-P;Drug: PlaceboGW Research LtdNULLCompleted1 Year65 YearsAll224Phase 3United States;Australia;Netherlands;Poland;Spain;United Kingdom
7EUCTR2015-002154-12-PL
(EUCTR)
18/11/2016A 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 Epidyolex 100 mg/ml oral solution,
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
INN or Proposed INN: N/A
Other descriptive name: CANNABIDIOL
GW Research Ltd.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Spain;Poland;Australia;Netherlands;United Kingdom
8EUCTR2020-002132-67-Outside-EU/EEA
(EUCTR)
22/10/2021Safety, Pharmacokinetics, and Exploratory Efficacy Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiseizure Medication, in Patients Age 1 Month to <12 Months of Age With Tuberous Sclerosis Complex Who Experience Inadequately-controlled SeizuresAn Open-Label, Randomized Trial to Assess the Safety, Pharmacokinetics, and Exploratory Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared with Standard of Care Antiseizure Medication, in Patients Age 1 Month to Less than 12 Months of Age with Tuberous Sclerosis Complex who Experience Inadequately-Controlled SeizuresP/0047/2020P/0350/2020P/0033/2021 Tuberous Sclerosis Complex (TSC)
MedDRA version: 21.0;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: PT;Classification code 10080584;Term: Tuberous sclerosis complex;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Cannabidiol Oral Solution, is known as Epidyolex 100 mg/mL oral solution and is the approved name in the EU. Epidiolex (cannabidiol) oral solution is the approved name in the US.
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
GW Research LtdNULLNAFemale: yes
Male: yes
Phase 3United States

193. プラダー・ウィリ症候群


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05098509
(ClinicalTrials.gov)
March 15, 202222/9/2021A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi SyndromeA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi SyndromePrader-Willi SyndromeDrug: RAD011;Drug: PlaceboRadius Pharmaceuticals, Inc.NULLNot yet recruiting8 Years65 YearsAll220Phase 2/Phase 3United States
2NCT03458416
(ClinicalTrials.gov)
September 6, 20182/3/2018A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi SyndromeA Multicenter, Open-Label Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: Cannabidiol Oral SolutionBenuvia Therapeutics Inc.NULLTerminated8 Years17 YearsAll7Phase 2United States
3NCT02844933
(ClinicalTrials.gov)
June 6, 201822/7/2016Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi SyndromeA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi SyndromePrader-Willi SyndromeDrug: Cannabidiol;Drug: PlaceboBenuvia Therapeutics Inc.NULLTerminated8 Years17 YearsAll7Phase 2United States

206. 脆弱X症候群


臨床試験数 : 104 薬物数 : 87 - (DrugBank : 32) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 79
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04977986
(ClinicalTrials.gov)
September 13, 202120/7/2021Clinical Study of Cannabidiol in Children and Adolescents With Fragile X SyndromeA 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 - RECONNECTFragile X SyndromeDrug: ZYN002 - transdermal gel;Drug: PlaceboZynerba Pharmaceuticals, Inc.NULLRecruiting3 Years17 YearsAll204Phase 3United States;Australia;Ireland;United Kingdom
2NCT03614663
(ClinicalTrials.gov)
June 12, 201810/7/2018Clinical 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 SyndromeFragile X SyndromeDrug: ZYN002 - CBD Transdermal Gel;Other: Placebo Transdermal GelZynerba Pharmaceuticals, Inc.NULLCompleted3 Years17 YearsAll212Phase 2/Phase 3United States;Australia;New Zealand
3EUCTR2021-002542-33-IE
(EUCTR)
10/08/2021Effects and Safety of Test drug ZYN002, applied as a gel onto the skin of children and adolescents with a certain hereditary disease called Fragile X SyndromeA 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 - RECONNECT - RECONNECT Fragile X syndrome (FXS) is a rare genetic disorder caused by the deficiency or absence of Fragile X mental retardation protein (FMRP), an RNA-binding protein and the gene product of the FMR1 gene. FXS is most commonly caused by silencing of the FMR1 gene due to a trinucleotide repeat expansion. In FXS patients, the relative absence of functional FMRP is associated with critical impairments in neurodevelopment and learning, as well as disruption to other neuronal and non-neuronal functions.
MedDRA version: 20.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: ZYN002
INN or Proposed INN: n/a
Other descriptive name: CANNABIDIOL
Zynerba Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
204Phase 3United States;Ireland;Australia;United Kingdom

226. 間質性膀胱炎(ハンナ型)


臨床試験数 : 143 薬物数 : 171 - (DrugBank : 56) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04349930
(ClinicalTrials.gov)
January 202113/4/2020The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)Interstitial Cystitis;Bladder Pain SyndromeDrug: Cannabidiol vaginal suppository;Drug: Placebo vaginal suppositoryUniversity of New MexicoNULLWithdrawn18 YearsN/AFemale0Phase 1United States

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004226-15-DK
(EUCTR)
26/10/201805/01/2018 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]
Product Name: Cannabidiol tablet 10 mg
Other descriptive name: CANNABIDIOL
Product Name: Dronabinol capsule 2.5. mg
INN or Proposed INN: DRONABINOL
King Christian 10th Hospital for RheumatologyNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark