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NCT03509285 · ClinicalTrials.gov registry record · Phase 1
A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users
A Phase 1 study, sponsored by SK Life Science.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT03509285 is a Phase 1 study that has completed, run by SK Life Science. The registered enrollment target is 53 participants.
The verdict
NCT03509285, a Phase 1 study, has completed, sponsored by SK Life Science.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience. In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a crossover design, with a wash-out period of at least 24 hours between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the Treatment phase and will be randomized to single oral doses of cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind, double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the Treatment phase will be at least 16 days.
Interventions
- DRUG Alprazolam
- DRUG Cenobamate
- DRUG Alprazolam Placebo
- DRUG Cenobamate placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2017-12-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03509285
The ClinicalTrials.gov registry entry for NCT03509285 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Alprazolam is the first listed.
NCT03509285 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03509285 about?
NCT03509285 is a clinical study titled "A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users". This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience. In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a ...
What is the current status of trial NCT03509285?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2017-03-08. Estimated completion is 2017-12-15.
What interventions are being tested in trial NCT03509285?
The interventions under investigation include: Alprazolam (DRUG), Cenobamate (DRUG), Alprazolam Placebo (DRUG), Cenobamate placebo (DRUG).
Who is sponsoring clinical trial NCT03509285?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
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