Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
With
H. Lundbeck A/S
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The patient or patient's legally authorized representative must sign and date the Institutional Review Board approved Informed Consent and HIPPA Authorization Form.
Male and female patients 18+ years of age with a clinical diagnosis of Tuberous Sclerosis who experience an average of at least three partial seizures every two months, of which one must be a complex partial seizure
Patient must be on at least one and a maximum of four AEDs. Patient must be on a stable AED dose regimen for at least 30 days prior to screening. Neither a Vagal Nerve Stimulator (VNS) nor the ketogenic diet will count as an AED
In the investigator's opinion, the patient or caregiver must be able to keep a seizure diary
An MRI in the last 5 years, or willingness to undergo an MRI as part of the screening process
You may not be if
Cause of patient's seizures is a neurologic disease that is not Tuberous Sclerosis
Current, clinical diagnosis of a major depressive episode or suicidal ideation
Patient is taking more than four concurrent AEDs. Note: VNS or ketogenic diet is allowed and will not be counted in the four allowed AEDs
Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan
Patient is currently abusing drugs or alcohol
Clareo Health | Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
