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Clinical Trials in the USA / NCT07723963
Starting soon Phase 2/3

A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy

NCT07723963 · tracked via the Priya Life Science USA tracker
Sponsor
Jazz Pharmaceuticals
Phase
Phase 2/3
Started
2026-09-18
Last updated
2026-09-02

Condition(s) studied

Juvenile Myoclonic Epilepsy

Investigational drug(s) / intervention(s)

JZP926 capsulePlacebo

JZP926 capsule: Oral administration BID according to body weight

Placebo: Oral administration BID according to body weight

Study summary

This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).

Eligibility

Sex
ALL
Min age
10 Years
Max age
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 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.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Arizona
Yale University New Haven Connecticut
Pediatric Epilepsy & Neurology Specialists Tampa Florida
Emory Healthcare Atlanta Georgia
Savannah Neurology Specialists Savannah Georgia
Hawaii Pacific Neuroscience, LLC Honolulu Hawaii
Consultants in Epilepsy and Neurology Boise Idaho
Louisiana State University Baton Rouge Louisiana
Corewell Health Grand Rapids Michigan
Saint Peter's University Hospital New Brunswick New Jersey
Boston Children's Health Physicians Hawthorne New York
Northwell Health - Division of Pediatric Neurology Lake Success New York
Weill Cornell Medicine - Pediatric Neurology New York New York
Cincinnati Children's Hospital Cincinnati Ohio
Oregon Health & Science University Portland Oregon
Sutter Health Dallas Texas
Carilion Clinic Neurology Roanoke Virginia
Sentara Neurology Specialists Virginia Beach Virginia
Winchester Neurological Consultants Winchester Virginia

More Jazz Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07723963 on ClinicalTrials.gov ↗ ← All trials in the USA