search
Back to results

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

Primary Purpose

Complex Partial Seizures

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
vigabatrin
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Partial Seizures focused on measuring Tuberous sclerosis, TS, Seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment with Sabril (vigabatrin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants Safely Tolerating Sabril
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

Secondary Outcome Measures

Number of Patients Who Become Seizure Free While Taking Sabril
Seizure freedom Responder rate (complex partial seizures only)

Full Information

First Posted
December 22, 2010
Last Updated
June 12, 2017
Sponsor
University of Pennsylvania
Collaborators
H. Lundbeck A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01266291
Brief Title
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
Acronym
STARS
Official Title
Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Was not possible to enroll sufficient number of subjects to draw any worthwhile conclusions from the study.
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Partial Seizures
Keywords
Tuberous sclerosis, TS, Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Sabril (vigabatrin)
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
vigabatrin
Other Intervention Name(s)
Sabril
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Safely Tolerating Sabril
Description
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
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.
Secondary Outcome Measure Information:
Title
Number of Patients Who Become Seizure Free While Taking Sabril
Description
Seizure freedom Responder rate (complex partial seizures only)
Time Frame
Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Pollard, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs