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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

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

NCT ID

NCT01266291

First Posted

December 22, 2010

Last Updated

June 12, 2017

Sponsor

University of Pennsylvania

Collaborators

H. Lundbeck A/S

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

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

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

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

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

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