Juvenile Myoclonic Epilepsy study: JZP926 capsule
Official title A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
ClinicalTrials.gov ID: NCT07723963
What this study is testing
What is JZP926 capsule?
An investigational oral capsule being studied as a potential treatment for Juvenile Myoclonic Epilepsy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine how safe and effective JZP926 is for treating juvenile myoclonic epilepsy.
- Who it's for
- Participants who have juvenile myoclonic epilepsy.
- What's involved
- Participants will take the JZP926 capsule and attend scheduled visits for medical checks and tests.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older
You may be able to join if
- 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.
You likely can't join if
- 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 how well it works measures, in the...
- 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.
See the full eligibility criteria
- 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.
- 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 how well it works 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.
- 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...
- 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 \ 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Tampa, Florida, United States
- Savannah, Georgia, United States
- Honolulu, Hawaii, United States
- Winchester, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tampa, Florida, United States; Savannah, Georgia, United States; Honolulu, Hawaii, United States; Winchester, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.