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 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
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Swetapadma Patnaik
650 721 1458
Recruiting