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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: Completed Phase 1 study, sponsored by SK Life Science.
NCT03509285 is a Phase 1 study that has completed, run by SK Life Science. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subjective Effect of Drug Liking "at this moment" \[0-100 scale, 0=Strong Disliking, 50=Neither Like nor Dislike, 100=Strong Liking\]
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 |
What the finished NCT03509285 record still lists
NCT03509285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 4 interventions - of which Alprazolam is the first listed.
NCT03509285 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03509285's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 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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