Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients

Complex Partial Seizures Clinical Trial

— STARS: TS  

Official title:

Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01266291
• Other study ID #: 811542
• Status: Terminated
• Phase: Phase 4
• First received: December 22, 2010
• Last updated: December 1, 2016
• Start date: August 2010
• Est. completion date: December 2013

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Partial Seizures
• Seizures
• Tuberous Sclerosis

Intervention

Drug:
• vigabatrin
Subjects will begin taking vigabatrin (Sabril) during the third month of the study. Upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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