CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9 enrolled
Drug / intervention
GWP42003-Pdrug
Likely dose
Not stated in 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/NCT02954887
NCT02954887Phase 3Completed
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A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study

Jazz Pharmaceuticals·interventional·Posted Nov 4, 2016·Updated Sep 2, 2022

In Brief

A Phase 3 clinical trial evaluating GWP42003-P for Infantile Spasms. Completed, enrolled 9 participants across 7 sites in 2 countries.

Detailed Summary

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfantile Spasms
CountriesPoland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 4, 2016
Enrollment StartMay 12, 2017
Primary CompletionJun 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.7 years ago

Interventions

GWP42003-Pdrug

Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.