A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Starting soon · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Juvenile Myoclonic Epilepsy
In brief
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Key facts
- Study ID
- NCT07723963
- Run by
- Jazz Pharmaceuticals
- People needed
- 260
- Starts
- 2026-09-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 10 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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.
You may not qualify if…
- Participants are excluded from the study if any of the following criteria apply:
- 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.
- Has clinically unstable or progressive epilepsy.
- Has clinically significant unstable medical condition(s), other than epilepsy, including unstable psychiatric disorders.
- Has a history of status epilepticus in the 3 months prior to screening.
- History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on the clinical judgement of the investigator following interview with the participant and/or caregiver.
- Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention.
- Is currently treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening.
- Has a body weight < 20 kg or > 150 kg.
- Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to screening.
- Is unwilling or unable to abstain from recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) for the duration of the study.
Where it is running
- Clinical Trial Site — New Haven, Connecticut, United States
- Clinical Trial Site — Tampa, Florida, United States
- Clinical Trial Site — Atlanta, Georgia, United States
- Clinical Trial Site — Savannah, Georgia, United States
- Clinical Trial Site — Honolulu, Hawaii, United States
- Clinical Trial Site — Hawthorne, New York, United States
- Clinical Trial Site — Cincinnati, Ohio, United States
- Clinical Trial Site — Portland, Oregon, United States
- Clinical Trial Site — Roanoke, Virginia, United States
- Clinical Trial Site — Winchester, Virginia, United States
Full record on ClinicalTrials.gov
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