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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by University of Pennsylvania.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
University of Pennsylvania Identifier:
First received: December 22, 2010
Last updated: January 17, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Complex Partial Seizures
Drug: vigabatrin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The degree to which vigabatrin (Sabril) is safely tolerated by Tuberous Sclerosis patients. [ Time Frame: every 3 months throughout the study ] [ Designated as safety issue: Yes ]
    • 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

Secondary Outcome Measures:
  • Efficacy [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
    • Seizure freedom
    • Responder rate (complex partial seizures only)
    • Barriers to accrual

Estimated Enrollment: 12
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01266291

Contact: John Pollard, MD 215-662-7227

United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: John Pollard, MD    215-662-7227   
Principal Investigator: John Pollard, MD         
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: John Pollard, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania Identifier: NCT01266291     History of Changes
Other Study ID Numbers: 811542 
Study First Received: December 22, 2010
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Tuberous sclerosis

Additional relevant MeSH terms:
Tuberous Sclerosis
Brain Diseases
Central Nervous System Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Malformations of Cortical Development
Malformations of Cortical Development, Group I
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Nervous System Diseases
Nervous System Malformations
Neurocutaneous Syndromes
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 26, 2016