Complex Partial Seizures Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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