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NCT03678753 · ClinicalTrials.gov registry record · Phase 3
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
A Phase 3 study, sponsored by SK Life Science.
- Completed
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
NCT03678753: Completed Phase 3 study, sponsored by SK Life Science.
NCT03678753 is a Phase 3 study that has completed, run by SK Life Science. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03678753, a Phase 3 study, has completed, sponsored by SK Life Science.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
Study Summary
This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects, adults and adolescents, will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% chance or receiving cenobamate or placebo (sugar pill). Subjects will initially receive 12.5 mg of cenobamate or placebo (study drug) and increase the dose every two weeks until they reach a target dose of 200 mg. Subjects will take study drug at approximately the same time in the morning (once a day) with or without food. If tolerability issues arise, dosing can be changed to evening. Also, once a subject reaches 200 mg, the dose can be decreased one time to 150 mg, if necessary. The treatment period is 22 weeks and there is a 3 week follow up period, which includes a one week decrease in study drug to 100 mg prior to stopping. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight. Subjects who complete may be eligible for an extension study and will not have to complete the follow up period. Subjects will track their seizure types and frequency in a diary throughout the study.
Primary Outcome
The seizure frequency over a specified period was calculated based on available seizure diary data. The percent change from baseline in PGTC seizure frequency during the Double-blind Treatment Period was calculated as the seizure frequency per 28-day interval during the Double-blind Treatment Period minus the seizure frequency per 28-day interval during the baseline period divided by the seizure frequency per 28-day interval during the baseline period and multiplied by 100%.
Interventions
- DRUG Placebo
- DRUG Cenobamate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2025-05-26 |
| Phase | Phase 3 |
What the finished NCT03678753 record still lists
NCT03678753 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03678753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03678753 about?
NCT03678753 is a clinical study titled "Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures". This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects, adults and adolescents, will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% c...
What is the current status of trial NCT03678753?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2018-10-03. Estimated completion is 2025-05-26.
What interventions are being tested in trial NCT03678753?
The interventions under investigation include: Placebo (DRUG), Cenobamate (DRUG).
Who is sponsoring clinical trial NCT03678753?
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 NCT03678753's enrollment target sits among peer trials
169 1459th of 2000 higher than 542 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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