DDrare: Database of Drug Development for Rare Diseases

Searched query = "West syndrome", "Infantile spasm"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 18 FDG; ACTH; Acetate; Adrenocorticotropin hormone; CANNABIDIOL; CBD; Cannabidiol; Cannabidiol (CBD); Cannabidiol Oral Solution; Combination therapy with vigabatrin and prednisolone; Cosyntropin; Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin; Cosyntropin Injectable Suspension, 1 mg/mL; Decortin H; Fenfluramine; GWP42003-P; Ganaxolone; Intravenous Methylprednisolone; JBPOS0101; M071754; Melatonin; Methylprednisolone; Modified Atkins diet; Null; Oral Pednisolone; Oral prednisolone; Other: modified Atkins diet; Prednisolone; Pyridoxine; Pyridoxine plus prednisolone; Radiprodil; SABRIL; SABRIL SACHETS; SOLUBLE PREDNISOLONE TABLETS; SPT3162; SYNACTHEN DEPOT; Sabril; Sabril granules for oral use; Sabrilex; Sabril®; Synacthen Depot; Tetracosactide; Tetracosactide Acetate; UCB3491; VGB-ST; VGB-ST soluble tablets; VIGABATRIN; Vigabatrin; Vigabatrin Tablets; Vigabatrin: Vigabatrin new ST formulation then Sabril®

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03421496 (ClinicalTrials.gov)	September 5, 2018	26/1/2018	A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms	A 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 Spasms	Infantile Spasm	Drug: Cannabidiol Oral Solution;Drug: Placebo;Drug: Vigabatrin	Benuvia Therapeutics Inc.	NULL	Terminated	1 Month	24 Months	All	2	Phase 3	United States

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agemin

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NCT03421496
(ClinicalTrials.gov)

September 5, 2018

26/1/2018

A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

A 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 Spasms

Infantile Spasm

Drug: Cannabidiol Oral Solution;Drug: Placebo;Drug: Vigabatrin

Benuvia Therapeutics Inc.

NULL

Terminated

1 Month

24 Months

All

Phase 3

United States