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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 is a Phase 3 study that has completed, run by SK Life Science. The registered enrollment target is 169 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03678753
The ClinicalTrials.gov registry entry for NCT03678753 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 169 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 2 interventions - of which Placebo is the first listed.
NCT03678753 reports 0 study locations.
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.
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