A Study to Treat Patients with Dravet Syndrome Using ZX008
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004051
NCT ID: NCT03780127
Sponsor Protocol Number: ZX008-1800
About this study
The purpose of this study is to provide patients with Dravet Syndrome, who do not qualify for participation in one of the ongoing ZX008 clinical trials, to receive treatment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Up to 50 patients with Dravet syndrome.
- Patients ≥ 1 year and older.
- Treating physicians must submit a clinical statement of potential benefit to the Sponsor, which includes patient’s gender, age, diagnosis, co-morbidities, seizure history, prior and current therapies, response to prior therapies, reason for request, and why the patient lacks other therapeutic options. Echocardiogram (ECHO) results must also be submitted prior to final approval.
- Inclusion of patients will be at the sole discretion of the Sponsor.
Exclusion Criteria:
- Patients with mild or greater mitral valve regurgitation and/or trace or greater aortic valve regurgitation will not be eligible for participation.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Elaine Wirrell, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available