JZP926 capsule for Juvenile Myoclonic Epilepsy: safety and seizure reduction in youths

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 trial to evaluate the safety and efficacy of JZP926 capsule as an add-on therapy for juvenile myoclonic epilepsy. Participants aged 10 years and up with JME will be assigned to receive either JZP926 or placebo, alongside their current treatment, to see if seizure days decrease and to monitor non-seizure outcomes. The study will collect data on safety and tolerability, with multiple international sites contributing to overall results. Eligibility requires confirmed JME diagnosis and a history of at least 4 myoclonic seizure days per 28 days. Interventions include JZP926 capsule and placebo, with outcomes focused on seizure frequency and broader clinical measures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Savannah Neurology Specialists
  Savannah, Georgia, United States Recruiting
• Hawaii Pacific Neuroscience, LLC
  Honolulu, Hawaii, United States Recruiting
• Winchester Neurological Consultants
  Winchester, Virginia, United States Recruiting
• Banner University Medical Center
  Phoenix, Arizona, United States Not yet recruiting
• UCLA Mattel Children's Hospital
  Los Angeles, California, United States Not yet recruiting
• Sutter Health
  Sacramento, California, United States Not yet recruiting

Study contacts

• Study coordinator: Clinical Trial Disclosure & Transparency
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Phone: 215-832-3750

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding the genetics of Juvenile Myoclonic Epilepsy

  This study is trying to find the genetic causes of Juvenile Myoclonic Epilepsy by collecting blood samples and health information from people with the condition and comparing it to data from those without epilepsy.

  Recruiting at 12 sites King's College London · New York, New York and 14 other locations · NCT03400371

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.