Spots Global Cancer Trial Database for Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
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Trial Identification
Brief Title: Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
Official Title: Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study
Study ID: NCT01266291
Conditions
Interventions
Study Description
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 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Contact Details
Name: John Pollard, MD
Affiliation: University of Pennsylvania
Role: PRINCIPAL_INVESTIGATOR
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