Safety and efficacy study of cannabidiol oral solution in children and adolescents with Epilepsy
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multisite, Phase 3 study to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P) in children and adolescents with epilepsy with myoclonic-atonic seizures
IRAS ID
1004794
Contact name
Anna Tarasiuk
Contact email
Sponsor organisation
GW Research Ltd
Eudract number
2021-003094-61
Clinicaltrials.gov Identifier
Research summary
The primary aim of Part A of the study is to assess the efficacy and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with EMAS. The primary aim of Part B of the study is to evaluate the long-term safety and tolerability of GWP42003-P in participants with EMAS.
This study will look at epilepsy with myoclonic-atonic seizures (EMAS), also called ‘Doose syndrome’ in children and adolescents. EMAS usually starts in early childhood and children may experience different types of seizures. The most common are drop seizures, characterised by an abrupt fall with loss of body tone (atonic) or by a brief body jerk followed by an abrupt fall (myoclonic atonic). Currently, there are no approved treatments specifically for this type of seizure.
As part of the clinical study, we plan to check if the study medicine can help to control seizures and is safe for children and adolescents with EMAS to use.
There are 2 parts
Part A of this clinical study, we will compare GWP42003-P with a dummy medicine (a placebo). A placebo is a medicine that looks, smells and tastes the same as GWP42003-P, but does not have any active ingredients in it.
• If it is appropriate to do so, at the end of Part A of this clinical study the child may be invited to take part in Part B. In Part B, all participants will receive GWP42003 P.
• Neither you nor your child’s study doctor will know which medicine the child is receiving until the study has finished.
The study medicine is known as an ‘investigational medicinal product’. This means it is a test medicine that hasn't been approved by MHRA for the treatment of EMAS.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0108
Date of REC Opinion
1 Jul 2022
REC opinion
Further Information Favourable Opinion