A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Recruiting
Phase 2Phase 3Interventional Study
Juvenile Myoclonic Epilepsy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
Jazz Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for people with Juvenile Myoclonic Epilepsy who have frequent myoclonic seizures. Participants will take a capsule called JZP926 and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
Must not be takingEpidiolexCannabis products
Rules you outNon-epileptic seizuresUnstable psychiatric disorders
You may be able to join if
I am at least 10 years old.
I have been diagnosed with Juvenile Myoclonic Epilepsy.
I have had at least 4 myoclonic seizure days in the last month.
You may not be able to join if
I have seizure types other than GTC, myoclonic, or absence seizures.
My MRI shows a cause of epilepsy other than Juvenile Myoclonic Epilepsy.
I have other confirmed seizure issues that might confuse results.
I have a progressive neurological disease affecting my seizures.
My epilepsy is unstable or getting worse.
I have other serious medical problems unrelated to epilepsy.
I have had status epilepticus in the past 3 months.
I have a history of suicidal thoughts or behaviors.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Trial Locations
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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 his…
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.
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