Complex Partial Seizures Clinical Trial
— STARS: TSOfficial title:
Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study
Verified date | December 2016 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 which the drug is approved. While enrolled on this trial, subjects
will continue to take all of their normally prescribed medications, including their other
antiepileptic drugs (AEDs).
Alternatively, there is a prospective observational arm that subjects who are about to take
Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who
join this arm will not have any study visits and will not be asked to do anything
specifically for the study. The study team will collect all study data from subjects'
medical records only.
Status | Terminated |
Enrollment | 1 |
Est. completion date | December 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The degree to which vigabatrin (Sabril) is safely tolerated by Tuberous Sclerosis patients. | Safety blood draws (AED levels, comprehensive panel, CBC with differential) Visual field tests, and ophthalmology exams Frequency and severity of adverse events reported by subjects throughout their involvement with the study |
every 3 months throughout the study | Yes |
Secondary | Efficacy | Seizure freedom Responder rate (complex partial seizures only) Barriers to accrual |
Duration of the study | No |
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