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

Updated 05/14/2024

Status Completed

Clinical Trial Summary

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02954887
Study type	Interventional
Source	Jazz Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	May 12, 2017
Completion date	June 13, 2019

See also
	Status	Clinical Trial	Phase
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	Completed	`NCT01006811` - Use of the Modified Atkins Diet in Infantile Spasms	Phase 2/Phase 3
	Completed	`NCT01828437` - Addition of Pyridoxine to Prednisolone in Infantile Spasms	Phase 3
	Recruiting	`NCT01858285` - Genetics of Epilepsy and Related Disorders
	Completed	`NCT00552045` - Epilepsy Phenome/Genome Project
	Not yet recruiting	`NCT06315829` - Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
	Completed	`NCT02220114` - Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy	N/A
	Completed	`NCT02092883` - Evaluation of Neuroinflammation in Children With Infantile Spasms	Phase 4
	Completed	`NCT01723787` - Genetic Studies in Patients and Families With Infantile Spasms
	Withdrawn	`NCT01413711` - An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms	Phase 4
	Terminated	`NCT00442104` - Open-label Extension to Protocol 1042-0500	Phase 2
	Completed	`NCT00441896` - A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms	Phase 2
	Withdrawn	`NCT01549288` - Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy	Phase 2/Phase 3
	Completed	`NCT01575639` - Prednisolone in Infantile Spasms- High Dose Versus Usual Dose	Phase 3
	Completed	`NCT01073579` - Sabril Patient Registry	N/A
	Completed	`NCT02953548` - Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)	Phase 3
	Completed	`NCT00001325` - Metabolic Abnormalities in Children With Epilepsy	N/A
	Completed	`NCT00968136` - Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study	N/A