About this trial
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is ≥ 10 years of age at the time of screening.
Has a diagnosis of JME per ILAE criteria as specified in the protocol.
Has at least 4 myoclonic seizure days per 28 days historical seizure frequency.
Disqualifiers
Presence of seizure types other than GTC, myoclonic, and absence seizures.
If historical MRI has been performed, participant's MRI reveals a cause of epilepsy other than JME.
Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.
The etiology of the participant's seizures is a progressive neurologic disease.
Trial design
Parallel
Treatments tested in this trial
JZP926 capsule
DrugOral administration BID according to body weight
Placebo
DrugOral administration BID according to body weight
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)
Secondary outcomes
Patient and Caregiver Global Impression of Change in Usual Daily Activities (P/CaGI-C UDA) (Part A and Part B)
Proportion of participants who achieve ≥ 50% and ≥ 75% reduction from baseline in myoclonic seizure days (Part A and Part B)
Change from baseline in days with any seizure type per 28 days (Part A and Part B)
Number of days with fewer myoclonic seizures than participant average prior to entering the study per 28 days (Part A and Part B)
Sponsors and contacts
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