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NCT02544763 · ClinicalTrials.gov registry record · Phase 3
A Randomized Controlled 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
- 224
- Enrollment target
NCT02544763 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 224 participants.
The verdict
NCT02544763, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 224 participants
- Enrollment target
Study Summary
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.
Interventions
- DRUG Placebo
- DRUG GWP42003-P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2016-04-06 |
| Est. Completion | 2019-02-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02544763
The ClinicalTrials.gov registry entry for NCT02544763 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02544763 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02544763 about?
NCT02544763 is a clinical study titled "A Randomized Controlled 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 blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP4...
What is the current status of trial NCT02544763?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2016-04-06. Estimated completion is 2019-02-26.
What interventions are being tested in trial NCT02544763?
The interventions under investigation include: Placebo (DRUG), GWP42003-P (DRUG).
Who is sponsoring clinical trial NCT02544763?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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