A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of JZP926 in Participants Aged 10 Years and Older for the Treatment of Juvenile Myoclonic Epilepsy
Jazz Pharmaceuticals
Summary
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Description
This Phase 2/3 multicenter, randomized, placebo-controlled, double-blind study will evaluate the safety and efficacy of JZP926 capsule in participants aged ≥ 10 years with Juvenile Myoclonic Epilepsy (JME). The study will assess the efficacy of JZP926 capsule as an adjunctive treatment in reducing the frequency of myoclonic seizure days when compared with placebo, as well as the effect of JZP926 capsule on non-seizure endpoints.
Eligibility
- Age range
- 10+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is ≥ 10 years of age at the time of screening. 2. Has a diagnosis of JME per ILAE criteria as specified in the protocol. 3. Has at least 4 myoclonic seizure days per 28 days historical seizure frequency. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. Presence of seizure types other than GTC, myoclonic, and absence seizures. 2. If historical MRI has been performed, participant's MRI reveals a cause of epilepsy other…