At a glance
ClinicalIndex Comparison RecordPhase 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.
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
In Brief
A Phase 3 clinical trial evaluating GWP42003-P for Infantile Spasms. Completed, enrolled 9 participants across 8 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 pilot phase only will be described in this record. 2 cohorts of 5 participants will be enrolled sequentially. 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 2016
Enrollment StartApr 2017
Primary CompletionMay 2018
TodayJul 2026
First PostedNov 2, 2016
Enrollment StartApr 24, 2017
Primary CompletionMay 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 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.