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NCT02224560 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT02224560: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT02224560 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02224560, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).
Primary Outcome
Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: (\[frequency during the treatment period - frequency during baseline\]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of sei
Interventions
- DRUG Placebo control
- DRUG GWP42003-P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2015-06-08 |
| Est. Completion | 2016-05-19 |
| Phase | Phase 3 |
What the finished NCT02224560 record still lists
NCT02224560 is an interventional study that assigns participants to a tested intervention. The registered 225 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo control is the first listed.
NCT02224560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02224560 about?
NCT02224560 is a clinical study titled "Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults". The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).
What is the current status of trial NCT02224560?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2015-06-08. Estimated completion is 2016-05-19.
What interventions are being tested in trial NCT02224560?
The interventions under investigation include: Placebo control (DRUG), GWP42003-P (DRUG).
Who is sponsoring clinical trial NCT02224560?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02224560's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 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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