Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

• Register: ClinicalTrials.gov
• Last refreshed on: 15 May 2023
• Main ID: NCT02849457
• Date of registration: 13/07/2016
• Prospective Registration: Yes
• Primary sponsor: Martina Bebin
• Public title: Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
• Scientific title: Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC
• Date of first enrolment: December 2016
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02849457
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Martina Bebin, MD, MPA
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion 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)



Age minimum: 1 Day
Age maximum: 6 Months
Gender: All

Health Condition(s) or Problem(s) studied

Tuberous Sclerosis Complex

Intervention(s)

Drug: Vigabatrin

Drug: Placebo

Primary Outcome(s)

Cognitive Assessment Scores and Developmental Impact [Time Frame: 24 months]

Secondary Outcome(s)

Evaluate Autism Diagnostic Observation Schedule 2nd Edition (ADOS2) Scores and Impact of Early Versus Late Treatment [Time Frame: 24 months and 36 months]

Evaluate Vineland II Scores and Impact of Early Versus Late Treatment [Time Frame: 12 months, 24 months and 36 months]

Number of Subjects with Vigabatrin Related Adverse Events and Severe Adverse Events [Time Frame: 24 months]

Prevalence of Drug Resistant Epilepsy [Time Frame: 24 months]

Time to the Subject's First Clinical Seizure [Time Frame: 24 months]

Number of subjects that develop seizures when treated with vigabatrin [Time Frame: 24 months]

EEG Biomarker for Developing Epilepsy [Time Frame: 24 months]

Secondary ID(s)

1U01NS092595-01A1

PREVeNT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)