Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
| Status: | Terminated |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2016 |
| Start Date: | August 2010 |
| End Date: | December 2013 |
Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study
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.
(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.
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
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