Trial Search Results

Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Martina Bebin

Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Stanford Investigator(s):

Intervention(s):

  • Drug: Vigabatrin
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. less than or equal to 6 months of age

   2. No history of seizures or infantile spasms, or evidence of subclinical electrographic
   seizures on a previous video EEG

   3. Meet genetic or clinical diagnostic criteria for TSC, the latter based on current
   recommendations for diagnostic evaluation, such as physical exam, neuroimaging,
   echocardiogram

Exclusion Criteria:

   1. Is greater than 6 months of age

   2. Has not been diagnosed with TSC

   3. History of seizures or infantile spasms, or evidence of subclinical electrographic
   seizures on a previous video EEG

   4. Has received any anticonvulsant medication including vigabatrin, other anti-seizure
   therapeutic agent including cannabidiol

   5. Has received an oral mTOR inhibitor such as everolimus or sirolimus

   6. Has taken an investigational drug, including but not limited to cannabidiol, as part
   of a research study 30 days prior to enrollment, or plans on taking an investigational
   drug at any time during the duration of the study

   7. Is currently enrolled, or plans on enrolling at any time during the duration of the
   study, in an experimental behavioral early intervention study

   8. Has a history of being born prematurely (born less than <30 weeks gestation at the
   time of delivery)

Ages Eligible for Study

N/A - 6 Months

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Swetapadma Patnaik
650 721 1458
Recruiting