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

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ClinicalTrials.gov Identifier: NCT01266291
Recruitment Status : Terminated (Was not possible to enroll sufficient number of subjects to draw any worthwhile conclusions from the study.)
First Posted : December 24, 2010
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Pennsylvania

December 22, 2010
December 24, 2010
April 19, 2017
July 12, 2017
July 12, 2017
August 2010
February 2013   (Final data collection date for primary outcome measure)
Number of Participants Safely Tolerating Sabril [ Time Frame: Outcome measures will be assessed at the initiation of Sabril (titration), and at three and five months after starting Sabril. After this time, the subjects will have completed the study. ]
  • Antiepileptic Drug (AED) levels in blood
  • Comprehensive panel (blood test)
  • Complete Blood Count with differential (blood test)
  • Visual field tests testing
  • Ophthalmology exam assessment
  • Frequency and severity of adverse events reported by subjects throughout their involvement with the study
The degree to which vigabatrin (Sabril) is safely tolerated by Tuberous Sclerosis patients. [ Time Frame: every 3 months throughout the study ]
  • 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
Complete list of historical versions of study NCT01266291 on ClinicalTrials.gov Archive Site
Number of Patients Who Become Seizure Free While Taking Sabril [ Time Frame: Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5) ]
  • Seizure freedom
  • Responder rate (complex partial seizures only)
Efficacy [ Time Frame: Duration of the study ]
  • Seizure freedom
  • Responder rate (complex partial seizures only)
  • Barriers to accrual
Not Provided
Not Provided
 
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Complex Partial Seizures
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.
Other Name: Sabril
Treatment with Sabril (vigabatrin)
This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: 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.
Intervention: Drug: vigabatrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
12
December 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01266291
811542
Yes
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
H. Lundbeck A/S
Principal Investigator: John Pollard, MD University of Pennsylvania
University of Pennsylvania
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP