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

GW Research Ltd.0 sites30 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

GW Research Ltd.

•Patient and/or parent(s)/legal representative must be willing and able
•to give informed assent/consent for participation in the study.;• Patient and their caregiver must be willing and able (in the
•investigator's opinion) to comply with all study requirements.;• Patient must be male or female aged between two and 18 years
•(inclusive).;• Patient must have a documented history of DS which is not completely
•controlled by current AEDs.;• Patient must be experiencing four or more convulsive seizures (i.e.,
•tonic\-clonic, tonic, clonic, atonic seizures) during the first 28 days of the
•baseline period.;• Patient must be taking one or more AEDs at a dose which has/have
•been stable for at least four weeks.;• All medications or interventions for epilepsy (including ketogenic diet
•and vagus nerve stimulation \[VNS]) must have been stable for four
•weeks prior to screening and patient and caregiver are willing to

•Patient has clinically significant unstable medical conditions other than
•epilepsy.;• Patient has had clinically relevant symptoms or a clinically significant
•illness in the four weeks prior to screening or randomization, other than
•epilepsy.;• Patient has clinically significant abnormal laboratory values, in the
•investigator's opinion, at screening or randomization.;• Patient has clinically relevant abnormalities in the ECG measured at
•screening or randomization.;• Patient has any concurrent cardiovascular conditions which will, in the
•investigator's opinion, interfere with the ability to assess their ECGs.;• Patient has a history or presence of alcohol or substance abuse within
•the last two years prior to the study or daily consumption of five or more
•alcohol\-containing beverages.;• Patient is currently using, or has in the past used, recreational or
•medicinal cannabis, or synthetic cannabinoid\-based medications

Not specified