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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 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 26 participants.
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.
Interventions
- DRUG Cannabidiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-09-18 |
| Est. Completion | 2019-06-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02286986
The ClinicalTrials.gov registry entry for NCT02286986 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cannabidiol is the first listed.
NCT02286986 reports 0 study locations.
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.
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