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NCT02286986 · ClinicalTrials.gov registry record · Phase 1
Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT02286986: Completed Phase 1 study, sponsored by University of Utah.
NCT02286986 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02286986, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P compared with placebo with respect to: * Incidence, type and severity of adverse events (AEs) * Effect on vital signs, including weight * Effect on 12-lead electrocardiogram (ECG) findings * Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic efficacy of GWP42003-P compared with placebo with respect to the incidence in convulsive seizures * To determine the plasma concentration time curves for GWP42003-P and its major human metabolite, following escalating multiple doses of GWP42003-P. * To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant anti-epileptic drugs (AEDs). * To evaluate cognitive function, sleep quality and daytime sleepiness, in patients taking GWP42003-P in combination with AEDs.
Primary Outcome
Number of Seizures
Interventions
- DRUG Cannabidiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-09-18 |
| Est. Completion | 2019-06-13 |
| Phase | Phase 1 |
What the finished NCT02286986 record still lists
NCT02286986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Cannabidiol is the first listed.
NCT02286986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02286986 about?
NCT02286986 is a clinical study titled "Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy". Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P compared with placebo with respect to: * Incidence, type and severity of adverse events (AEs) * Effect on vital signs, including weight * Effect on 12-lead electrocardiogram (ECG) findings * Effect on laborato...
What is the current status of trial NCT02286986?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2014-09-18. Estimated completion is 2019-06-13.
What interventions are being tested in trial NCT02286986?
The interventions under investigation include: Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT02286986?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02286986's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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