Clinical trial NCT01266291: Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Complex Partial Seizures
Keywords: Tuberous sclerosis
TS
Seizures
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2010-12-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants Safely Tolerating Sabril
timeFrame: 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 outcomes:
measure: Number of Patients Who Become Seizure Free While Taking Sabril
timeFrame: Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: John Pollard, MD
role: PRINCIPAL_INVESTIGATOR
References: