Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martina Bebin
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Vigabatrin

Criteria

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)