A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome.

GWEP1424

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

2015-04-13

2018-04-09

2018-04-09

Completed

Early phase I

199

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.

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2022-09-28