Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasms

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Sclerosis

Seizures

Tuberous Sclerosis

Neurologic Manifestations

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Anticonvulsants

All Drugs and Chemicals

Vigabatrin

Enzyme Inhibitors

Neurotransmitter Agents

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.

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.

vigabatrin

John Pollard, MD

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.

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

* 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

* Seizure freedom
* Responder rate (complex partial seizures only)

H. Lundbeck A/S

University of Pennsylvania

The study team used clinicaltrials.gov definitions for adverse events and serious adverse events.

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 by 1 gm/week for one month under the supervision of the study doctor.

Age, Categorical

Age, Continuous

Treatment

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The study was terminated due to insufficient enrollment; 98 potentially eligible patients were pre-screened and only one enrolled. The study was not terminated due to concerns regarding safety or efficacy.

One 30 year old female, Caucasian, non-Hispanic subject enrolled in the study. Due to adverse events, she did not complete the study, however, she completed all required follow-up.

Number of Participants Safely Tolerating Sabril

Number of Patients Who Become Seizure Free While Taking Sabril

The interventional arm of this phase 4 study involved subjects taking vigabatrin (Sabril) in accordance with standard of care, FDA approved dosing instructions. There were no planned arms; all subjects followed the FDA-approved prescribing label.

As there were not multiple treatment arms under investigation, per the FDA-approved prescribing label, the one and only subject who enrolled underwent upward titration happened at a rate of 500mg per week until she reached her maximum tolerated dose, or 3g per day. This dose was decreased as needed under the supervision of the study doctor. Again in accordance with standard of care, FDA-approved prescribing guidelines, when she stopped taking Sabril, her dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients	NCT01266291	Complex Partial...	vigabatrin	18 Years -	University of Pennsylvania
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients	NCT01266291	Complex Partial...	vigabatrin	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for complex partial seizures