JZP926 for Juvenile Myoclonic Epilepsy

Not yet recruiting at 28 trial locations
CT
Overseen ByClinical Trial Disclosure & Transparency
Age: Any Age
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Jazz Pharmaceuticals
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Juvenile Myoclonic Epilepsy (JME). Participants must meet specific medical criteria set by the study, but detailed inclusion and exclusion requirements are not provided here.

Inclusion Criteria

I have been diagnosed with juvenile myoclonic epilepsy.
I am at least 10 years old.
I have at least 4 days with myoclonic seizures every 28 days.

Exclusion Criteria

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 a body weight < 20 kg or > 150 kg
My seizures are caused by a worsening brain or nerve disease.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JZP926 or placebo for a 16-week treatment period

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of JZP926 treatment for up to 52 weeks

52 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new medication called JZP926 capsule to a placebo (a pill with no active drug) to see if it is safe and effective in treating JME. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label Extension: JZP926 CapsuleExperimental Treatment1 Intervention
Group II: JZP926 CapsuleExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials
252
Recruited
35,100+
Bruce C. Cozadd profile image

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin profile image

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland