GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

• Status: Completed
• Trial end date: 2018-04-09
• 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:

• Participant must have been male or female, aged between 2 and 18 years (inclusive).

• Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs.

• Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks.

• All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study.

Key Exclusion Criteria:

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

• Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy.

• Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study.

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

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

• Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Children's) at screening.