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NCT02224703 · ClinicalTrials.gov registry record · Phase 3

GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

A Phase 3 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
199
Enrollment target

NCT02224703: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.

NCT02224703 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 199 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02224703, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
199 participants
Enrollment target

Study Summary

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

Primary Outcome

Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an interactive voice response system (IVRS) diary. The primary endpoint was analyzed using negative binomial regression on the sum of the convulsive seizure counts during the treatment period, based on the ITT analysis set. Baseline included all available data prior to Day 1. Data

Interventions

  • DRUG Placebo Control
  • DRUG GWP42003-P

Trial Details

FieldValue
Enrollment Target 199 participants
Start Date 2015-04-13
Est. Completion 2018-04-09
Phase Phase 3
Jazz Pharmaceuticals

128 total trials

What the finished NCT02224703 record still lists

NCT02224703 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo Control is the first listed.

NCT02224703 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02224703 about?

NCT02224703 is a clinical study titled "GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome". To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

What is the current status of trial NCT02224703?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2015-04-13. Estimated completion is 2018-04-09.

What interventions are being tested in trial NCT02224703?

The interventions under investigation include: Placebo Control (DRUG), GWP42003-P (DRUG).

Who is sponsoring clinical trial NCT02224703?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02224703's enrollment target sits among peer trials

199 1388th of 2000 higher than 612 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02224703, the US trial registry maintained by the National Library of Medicine. NCT02224703 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.