Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01266291
Status:
TERMINATED
Last Update Posted:
2017-07-12
First Post:
2010-12-22
Brief Title:
Sabril for Complex Partial Seizures in Adult Tolerability Study TS Patients
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis An Open Label Phase IV Prospective Safety and Tolerability Study
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Was not possible to enroll sufficient number of subjects to draw any worthwhile conclusions from the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARS
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None