Cannabidiol Oral Solution ( DrugBank: Cannabidiol )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
140ドラベ症候群2
144レノックス・ガストー症候群3
145ウエスト症候群1
193プラダー・ウィリ症候群5

140. ドラベ症候群


臨床試験数 : 116 薬物数 : 65 - (DrugBank : 17) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 64
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04485104
(ClinicalTrials.gov)
May 19, 202121/7/2020Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled SeizuresAn Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled SeizuresSeizure in Participants With Tuberous Sclerosis Complex;Seizure in Participants With Dravet Syndrome;Seizure in Participants With Lennox-Gastaut SyndromeDrug: GWP42003-PJazz PharmaceuticalsNULLRecruiting1 Month23 MonthsAll27Phase 3United States
2NCT02318563
(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

144. レノックス・ガストー症候群


臨床試験数 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04485104
(ClinicalTrials.gov)
May 19, 202121/7/2020Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled SeizuresAn Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled SeizuresSeizure in Participants With Tuberous Sclerosis Complex;Seizure in Participants With Dravet Syndrome;Seizure in Participants With Lennox-Gastaut SyndromeDrug: GWP42003-PJazz PharmaceuticalsNULLRecruiting1 Month23 MonthsAll27Phase 3United 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-PJazz PharmaceuticalsNULLWithdrawn3 Years10 YearsAll0Phase 4United States
3NCT02318537
(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

145. ウエスト症候群


臨床試験数 : 43 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26
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

193. プラダー・ウィリ症候群


臨床試験数 : 113 薬物数 : 111 - (DrugBank : 26) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 102
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05387798
(ClinicalTrials.gov)
January 202317/5/2022A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi SyndromeA Phase 3, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: RAD011Radius Pharmaceuticals, Inc.NULLWithdrawn8 Years65 YearsAll0Phase 3NULL
2NCT05098509
(ClinicalTrials.gov)
April 13, 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.NULLTerminated8 Years65 YearsAll7Phase 2/Phase 3United States
3NCT03458416
(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
4NCT02844933
(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
5EUCTR2021-005331-23-SE
(EUCTR)
18/05/2022A 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 Syndrome Hyperphagia related behavior associated with Prader-Willi Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: RAD011
Product Code: RAD011
INN or Proposed INN: Cannabidiol
Radius Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 2;Phase 3France;United States;Canada;Belgium;Spain;Australia;United Kingdom;Italy;Sweden