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
2	NCT02954887 (ClinicalTrials.gov)	May 12, 2017	2/11/2016	Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)	A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study	Infantile Spasms	Drug: GWP42003-P	GW Research Ltd	NULL	Completed	1 Month	24 Months	All	9	Phase 3	United States;Poland
3	NCT02953548 (ClinicalTrials.gov)	April 24, 2017	1/11/2016	Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)	A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study	Infantile Spasms	Drug: GWP42003-P	GW Research Ltd	NULL	Completed	1 Month	24 Months	All	9	Phase 3	United States;Poland
4	EUCTR2015-004904-50-PL (EUCTR)		04/04/2017	Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms	A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study.	Infantile Spasms MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		GW Research Ltd	NULL	Not Recruiting			Female: yes Male: yes	202	Phase 3	United States;Hungary;Poland;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

NCT02954887
(ClinicalTrials.gov)

May 12, 2017

2/11/2016

Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)

A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study

Infantile Spasms

Drug: GWP42003-P

GW Research Ltd

NULL

Completed

1 Month

24 Months

All

Phase 3

United States;Poland

NCT02953548
(ClinicalTrials.gov)

April 24, 2017

1/11/2016

Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)

Infantile Spasms

Drug: GWP42003-P

GW Research Ltd

NULL

Completed

1 Month

24 Months

All

Phase 3

United States;Poland

EUCTR2015-004904-50-PL
(EUCTR)

04/04/2017

Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms

A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study.

Infantile Spasms
MedDRA version: 20.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

GW Research Ltd

NULL

Not Recruiting

Female: yes
Male: yes

202

Phase 3

United States;Hungary;Poland;Italy;United Kingdom