Juvenile Myoclonic EpilepsyPhase 2/3NCT07723963
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
A Phase 2/3 study testing JZP926 capsule in people with Juvenile Myoclonic Epilepsy, run by Jazz Pharmaceuticals at 20 sites in United States.
Trial summary
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Juvenile Myoclonic Epilepsy
- What is being tested?
- JZP926 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 20 sitesUnited States
- Study dates
- 18 Sep 2026to 1 Aug 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Not yet recruiting
Emory Healthcare
Atlanta, Georgia, 30329
- Not yet recruiting
Consultants in Epilepsy and Neurology
Boise, Idaho, 83702
- Not yet recruiting
Northwesthern Medicine
Chicago, Illinois, 60611
- Not yet recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Not yet recruiting
Scottish Rite Hospital
Dallas, Texas, 75219
- Not yet recruiting
Corewell Health
Grand Rapids, Michigan, 49503
- Not yet recruiting
Boston Children's Health Physicians
Hawthorne, New York, 10532
- Recruiting
Hawaii Pacific Neuroscience, LLC
Honolulu, Hawaii, 96817
- Not yet recruiting
Northwell Health - Division of Pediatric Neurology
Lake Success, New York, 11042
- Not yet recruiting
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
- Not yet recruiting
Yale University
New Haven, Connecticut, 06510
- Not yet recruiting
Weill Cornell Medicine - Pediatric Neurology
New York, New York, 10021
- Not yet recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
- Not yet recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Not yet recruiting
Carilion Clinic Neurology
Roanoke, Virginia, 24016
- Not yet recruiting
Sutter Health
Sacramento, California, 95816
- Recruiting
Savannah Neurology Specialists
Savannah, Georgia, 31406
- Not yet recruiting
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609
- Not yet recruiting
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456
- Recruiting
Winchester Neurological Consultants
Winchester, Virginia, 22601
About this study
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of JZP926 in Participants Aged 10 Years and Older for the Treatment of Juvenile Myoclonic Epilepsy
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Read the detailed description
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.
- Conditions
- Juvenile Myoclonic Epilepsy
- Being tested
- JZP926 capsule, Placebo
- Keywords
- Juvenile myoclonic epilepsy, JME, JZP926 capsule
- Medical subject headings
- Myoclonic Epilepsy, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JZP926 capsuleDrug
Oral administration BID according to body weight
PlaceboDrug
Oral administration BID according to body weight
| Study group | Role | What they receive |
|---|---|---|
| JZP926 Capsule | Experimental | Participants with JME will be randomized to JZP926 capsule based on weight-tiered dosing for a 16-week treatment period. Receives: Drug: JZP926 capsule |
| Placebo | Placebo comparator | Participants with JME will be randomized to matching placebo based on weight-tiered dosing for a 16-week treatment period. Receives: Drug: Placebo |
| Open-Label Extension: JZP926 Capsule | Experimental | 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. Receives: Drug: JZP926 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)
Measured: Baseline up to end of 16 weeks treatment period
Secondary outcomes (9)
Patient and Caregiver Global Impression of Change in Usual Daily Activities (P/CaGI-C UDA) (Part A and Part B)
Measured: Week 16
Proportion of participants who achieve ≥ 50% and ≥ 75% reduction from baseline in myoclonic seizure days (Part A and Part B)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline up to end of 16 weeks treatment period
Number of participants reporting treatment-emergent adverse events (Part A and Part B)
Measured: Baseline up to end of 16 weeks treatment period
Mean plasma concentration for CBD
Measured: Baseline up to end of 16 weeks treatment period
Mean plasma concentration of metabolite 7-OH-CBD
Measured: Baseline up to end of 16 weeks treatment period
Mean plasma concentration of metabolite 7-COOH-CBD
Measured: Baseline up to end of 16 weeks treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start18 Sep 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Myoclonic EpilepsyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723963
- Sponsor's protocol ID
- JZP926-203
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of JZP926 in Participants Aged 10 Years and Older for the Treatment of Juvenile Myoclonic Epilepsy
- ClinicalTrials.gov ID
- NCT07723963
- Acronym / sponsor ID
- JZP926-203
- Conditions
- Juvenile Myoclonic Epilepsy
- Keywords
- Juvenile myoclonic epilepsy, JME, JZP926 capsule
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JZP926 Capsule | Experimental | Drug: JZP926 capsuleParticipants with JME will be randomized to JZP926 capsule based on weight-tiered dosing for a 16-week treatment period. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants with JME will be randomized to matching placebo based on weight-tiered dosing for a 16-week treatment period. |
| Open-Label Extension: JZP926 Capsule | Experimental | Drug: JZP926 capsuleParticipants 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JZP926 capsuleOral administration BID according to body weight | Drug | JZP926 Capsule, Open-Label Extension: JZP926 Capsule |
| PlaceboOral administration BID according to body weight | Drug | Placebo |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Juvenile Myoclonic Epilepsy
RecruitingObservational study
Biology of Juvenile Myoclonic Epilepsy
Juvenile Myoclonic Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JZP926 capsule in people with Juvenile Myoclonic Epilepsy, run by Jazz Pharmaceuticals at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.