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Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures

NCT03678753 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2025-07-09

No results posted yet for this 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.

Conditions

  • Primary Generalized Epilepsy

Interventions

DRUG

Cenobamate

12.5 mg tablet, 25 mg tablet, 50 mg tablet, 100 mg tablets, 150 mg tablets, 200 mg tablets. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Sunita Misra, MD · SK Life Science, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2025-05-26
Completion
2025-05-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Poland
  • Slovakia
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678753 on ClinicalTrials.gov