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

Korábbi kezelés

• 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.
• Has a history of status epilepticus in the 3 months prior to screening.
• Is currently treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening.
• 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.

Más betegség

• 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.
• The etiology of the participant's seizures is a progressive neurologic disease.
• Has clinically unstable or progressive epilepsy.
• Has clinically significant unstable medical condition(s), other than epilepsy, including unstable psychiatric disorders.
• 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.

Egyéb

• Participants are excluded from the study if any of the following criteria apply:
• Has a body weight < 20 kg or > 150 kg.

• 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.