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Neurodevelopmental Outcomes From the PREVeNT Trial.

Sarah E O'Kelley1, Jamie K Capal2, Tarrant O McPherson3

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|October 8, 2025
PubMed
Summary

Vigabatrin did not significantly alter developmental or autism outcomes in infants with Tuberous Sclerosis Complex (TSC). No participants without epilepsy were diagnosed with autism spectrum disorder (ASD).

Keywords:
AutismDevelopmentTuberous sclerosis complexVigabatrin

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Area of Science:

  • Neuroscience
  • Developmental Pediatrics
  • Genetics

Background:

  • Tuberous Sclerosis Complex (TSC) is a genetic disorder linked to high rates of epilepsy, intellectual disability, and autism spectrum disorder (ASD).
  • Early intervention is crucial for managing TSC-related neurodevelopmental challenges.

Purpose of the Study:

  • To evaluate the efficacy of vigabatrin in preventing intellectual and developmental disability and ASD in infants with TSC.
  • To assess phenotypic, developmental, and ASD-specific outcomes at 36 months in the PREVeNT trial.

Main Methods:

  • The PREVeNT trial was a Phase IIb, multicenter, double-blind, placebo-controlled study involving 84 infants with TSC.
  • Neurodevelopmental assessments were conducted from 6 to 36 months, with ASD diagnosis determined at 36 months.

Main Results:

  • Cognitive scores were in the low average range and declined slightly over time. Adaptive scores were lower in seizure groups.
  • Language scores aligned with cognitive scores by 36 months. 31% of participants were diagnosed with ASD, irrespective of treatment.
  • No significant differences in developmental or ASD outcomes were observed between vigabatrin and placebo groups.

Conclusions:

  • Vigabatrin did not show significant efficacy in preventing developmental or autism-specific outcomes in infants with TSC.
  • The study suggests early seizure detection and close monitoring may influence outcomes.
  • No participants without epilepsy developed ASD, highlighting the critical link between epilepsy and ASD in TSC.