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

This study is currently recruiting participants.
Verified January 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01266291
First received: December 22, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

Drug Information available for: Vigabatrin
U.S. FDA Resources

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266291

Contacts
Contact: John Pollard, MD 215-662-7227

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: John Pollard, MD     215-662-7227     john.pollard@uphs.upenn.edu    
Principal Investigator: John Pollard, MD            
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: John Pollard, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov 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
TS
Seizures

Additional relevant MeSH terms:
Seizures
Tuberous Sclerosis
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Hamartoma
Neoplasms
Malformations of Cortical Development
Nervous System Malformations
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
 Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Vigabatrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013