A Phase 2/3 interventional study of JZP926 capsule and Placebo in Juvenile Myoclonic Epilepsy, sponsored by Jazz Pharmaceuticals. Recruiting at 23 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Jazz Pharmaceuticals · Phase 2/3, Interventional, and Treatment
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
This Phase 2/3 multicenter, randomized, placebo-controlled, double-blind study will evaluate the safety and efficacy of JZP926 capsule in participants aged ≥ 10 years with Juvenile Myoclonic Epilepsy (JME). The study will assess the efficacy of JZP926 capsule as an adjunctive treatment in reducing the frequency of myoclonic seizure days when compared with placebo, as well as the effect of JZP926 capsule on non-seizure endpoints.
Jazz Pharmaceuticals is the lead sponsor of 173 studies on the registry; 18 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 32 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with JME will be randomized to JZP926 capsule based on weight-tiered dosing for a 16-week treatment period.
Drug: JZP926 capsule
Participants with JME will be randomized to matching placebo based on weight-tiered dosing for a 16-week treatment period.
Drug: Placebo
Participants completing Part A or Part B will have the option to continue into an open-label extension for up to 52 weeks, inclusive of a 4 week blinded transition.
Drug: JZP926 capsule
Oral administration BID according to body weight
Oral administration BID according to body weight
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
Patient and Caregiver Global Impression of Change in Usual Daily Activities (P/CaGI-C UDA) (Part A and Part B)
Time frame: Week 16
Proportion of participants who achieve ≥ 50% and ≥ 75% reduction from baseline in myoclonic seizure days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Change from baseline in days with any seizure type per 28 days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Number of days with fewer myoclonic seizures than participant average prior to entering the study per 28 days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Percent change from baseline (historical + prospective) in generalized tonic-clonic (GTC) seizure frequency (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Number of participants reporting treatment-emergent adverse events (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Mean plasma concentration for CBD
Time frame: Baseline up to end of 16 weeks treatment period
Mean plasma concentration of metabolite 7-OH-CBD
Time frame: Baseline up to end of 16 weeks treatment period
Mean plasma concentration of metabolite 7-COOH-CBD
Time frame: Baseline up to end of 16 weeks treatment period
Plan to share: Yes — In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Data sharing details ↗ · www.jazzpharma.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Myoclonic Epilepsy, Juvenile