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)
Change from baseline in myoclonic seizure days per 28 days (Part A and Part B) — Baseline up to end of 16 weeks treatment period
Trial sites (19)
Facility
City
Region
Status
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
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.
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