A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy

Conditions

• Juvenile Myoclonic Epilepsy

Eligibility Criteria

Sex

ALL

Age

10 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• JZP926 capsule — DRUG
  Oral administration BID according to body weight
• Placebo — DRUG
  Oral administration BID according to body weight

Study Details

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

Key Dates

First listed

Jul 23, 2026

Start date

Sep 1, 2026

Status verified

Jul 2026

Primary completion

Aug 1, 2028

Completion

Aug 1, 2028

Study Design

Enrollment

260 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: JZP926 Capsule
  Participants with JME will be randomized to JZP926 capsule based on weight-tiered dosing for a 16-week treatment period.
• Placebo Comparator: Placebo
  Participants with JME will be randomized to matching placebo based on weight-tiered dosing for a 16-week treatment period.
• Experimental: Open-Label Extension: JZP926 Capsule
  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.

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 ]

Central Contacts

• Clinical Trial Disclosure & Transparency
  215-832-3750
  [email protected]

Locations (10)

Find similar trials in New Haven, CT

Related Studies

• Biology of Juvenile Myoclonic Epilepsy
  Recruiting · King's College London · New York, New York