NCT07723963 A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
| NCT ID | NCT07723963 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Jazz Pharmaceuticals |
| Condition | Juvenile Myoclonic Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2026-09-18 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 260 participants in total. It began in 2026-09-18 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Eligibility Criteria
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 than JME. 3. 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. 4. The etiology of the participant's seizures is a progressive neurologic disease. 5. Has clinically unstable or progressive epilepsy. 6. Has clinically significant unstable medical condition(s), other than epilepsy, including unstable psychiatric disorders. 7. Has a history of status epilepticus in the 3 months prior to screening. 8. 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. 9. Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention. 10. Is currently treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening. 11. Has a body weight \< 20 kg or \> 150 kg. 12. 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. 13. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07723963 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Juvenile Myoclonic Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07723963 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07723963 currently recruiting?
Yes, NCT07723963 is actively recruiting participants. Contact the research team at ClinicalTrialDisclosure@JazzPharma.com for enrollment information.
Where is the NCT07723963 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Sacramento, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT07723963 clinical trial?
NCT07723963 is sponsored by Jazz Pharmaceuticals. The trial plans to enroll 260 participants.
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