A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)

• Status: Completed
• Trial end date: 2015-03-09
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and pharmacokinetics (PK) of multiple doses of GWP42003-P compared with placebo in children with Dravet syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GW Research Ltd
• Treatments: Cannabidiol; Pharmaceutical Solutions

Criteria

Key Inclusion Criteria:

• Participants were male or female aged between 4 and 10 years (inclusive).

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

• Participants took one or more AEDs at a dose which had been stable for at least 4 weeks.

• Participants had experienced fewer than 4 convulsive seizures (tonic-clonic, tonic, clonic, atonic seizures) during the 28-day baseline period.

• All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation [VNS]) were stable for four weeks prior to screening and participants were willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments were not counted as an AED.

Key Exclusion Criteria:

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

• Participants had clinically relevant abnormalities in the 12-lead electrocardiogram measured at screening or randomization.

• Participants were currently using or had in the past used recreational or medicinal cannabis, or synthetic CBD based medications (including Sativex®) within the 3 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 IMP.

• Participants who had been part of a clinical trial involving another investigational product in the previous 6 months.

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

• Participants were previously randomized into this study. In particular, participants participating in Part A of the study cannot enter Part B.