NCT07723963 · Jazz Pharmaceuticals
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
What this study is about
This study is being conducted to evaluate the safety and effectiveness of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
View original scientific description
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Interventions
DRUG
JZP926 capsule
Oral administration BID according to body weight
DRUG
Placebo
Oral administration BID according to body weight
Primary outcome measures
Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Phoenix, Arizona
- Sacramento, California
- New Haven, Connecticut
- Tampa, Florida
- Atlanta, Georgia
- Savannah, Georgia
- Honolulu, Hawaii
- Boise, Idaho
- Chicago, Illinois
- Grand Rapids, Michigan
- New Brunswick, New Jersey
- Hawthorne, New York
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations