Status:
TERMINATED
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Complex Partial Seizures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial epilepsy population for...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01266291
Start Date
August 1 2010
End Date
December 1 2013
Last Update
July 12 2017
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103