A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age10+
SponsorJazz Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JZP926 capsule

    Drug

    Oral administration BID according to body weight

  • Placebo

    Drug

    Oral administration BID according to body weight

Treatment groups

260 Participants
are divided into 3 treatment groups
Group A: JZP926 CapsuleExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Open-Label Extension: JZP926 CapsuleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Patient and Caregiver Global Impression of Change in Usual Daily Activities (P/CaGI-C UDA) (Part A and Part B)

Time frame
Week 16
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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