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NCT02544750 · ClinicalTrials.gov registry record · Phase 3
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 199
- Enrollment target
NCT02544750: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT02544750 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.
The verdict
NCT02544750, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
Study Summary
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
Primary Outcome
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. A serious AE was defined as any AE that results in any of th
Interventions
- DRUG GWP42003-P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2016-08-31 |
| Est. Completion | 2021-06-11 |
| Phase | Phase 3 |
What the finished NCT02544750 record still lists
NCT02544750 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 1 intervention - of which GWP42003-P is the first listed.
NCT02544750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02544750 about?
NCT02544750 is a clinical study titled "An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)". This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's do...
What is the current status of trial NCT02544750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2016-08-31. Estimated completion is 2021-06-11.
What interventions are being tested in trial NCT02544750?
The interventions under investigation include: GWP42003-P (DRUG).
Who is sponsoring clinical trial NCT02544750?
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 NCT02544750'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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