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	EUCTR2014-000360-17-FR (EUCTR)		17/06/2015	Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.	Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.Observational, descriptive, open-label, multi-centric, non-randomized study - SOLUWEST	Infantile spasms and pharmaco-resistant partial epilepsy MedDRA version: 18.0;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: LLT;Classification code 10065336;Term: Partial epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: vigabatrin Product Code: VGB-ST INN or Proposed INN: VIGABATRIN Other descriptive name: VGB-ST soluble tablets Trade Name: Sabril granules for oral use	TARGEON	NULL	NA			Female: yes Male: yes		Phase 2	France

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

EUCTR2014-000360-17-FR
(EUCTR)

17/06/2015

Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.

Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.Observational, descriptive, open-label, multi-centric, non-randomized study - SOLUWEST

Infantile spasms and pharmaco-resistant partial epilepsy
MedDRA version: 18.0;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;Level: LLT;Classification code 10065336;Term: Partial epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: vigabatrin
Product Code: VGB-ST
INN or Proposed INN: VIGABATRIN
Other descriptive name: VGB-ST soluble tablets
Trade Name: Sabril granules for oral use

TARGEON

NULL

Female: yes
Male: yes

Phase 2

France