CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
GWP42003-P 5 mg/kg/day Dose +3 moredrug
Likely dose
GWP42003-P 5 mg/kg/day Dosefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02091206
NCT02091206Phase 2Completed
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A Double Blind, Placebo-controlled, Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Jazz Pharmaceuticals·interventional·Posted Mar 19, 2014·Updated Sep 28, 2022

In Brief

A Phase 2 clinical trial evaluating GWP42003-P 5 mg/kg/day Dose, Placebo control, and 2 other interventions for Epilepsy and Dravet Syndrome. Completed, enrolled 34 participants across 11 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Dravet Syndrome
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 19, 2014
Enrollment StartOct 22, 2014
Primary CompletionMar 9, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.3 years ago

Interventions

GWP42003-P 5 mg/kg/day Dosedrug

GWP42003-P was an oral solution containing 25 mg/milliliter (mL) cannabidiol (CBD) or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day.

Placebo controldrug

Placebo oral solution contained the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).

GWP42003-P 10 mg/kg/day Dosedrug

GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day.

GWP42003-P 20 mg/kg/day Dosedrug

GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day.