Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)

• Status: Completed
• Trial end date: 2015-11-26
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GW Research Ltd
• Treatments: Cannabidiol

Criteria

Key Inclusion Criteria:

• Participants were male or female aged between 2 and 18 years (inclusive).

• Participants had a documented history of Dravet Syndrome that was not completely controlled by current antiepileptic drugs.

• Participants took one or more antiepileptic drugs at a dose that had been stable for at least four weeks.

• All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) were stable for four weeks prior to screening and participants were willing to maintain a stable regimen throughout the study.

Key Exclusion Criteria:

• Participants had clinically significant unstable medical conditions other than epilepsy.

• Participants had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy.

• Participants were currently using or had in the past used recreational or medicinal cannabis or synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry and were unwilling to abstain for the duration for the study.

• Participants had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.

• Participants had been part of a previous clinical trial involving another investigational product in the previous six months.

• There were plans for the participants to travel outside their country of residence during the study.

• Participants previously randomized into this study. In particular, participants who participated in Part A of the study could not enter Part B.