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NCT07433517Possibly a fitNot yet recruiting

Gene therapy trial for autism with severe behavior problems

Autism Spectrum Disorder

Part of Mental health clinical trials.

This trial tests an experimental gene therapy (VGN-Ex05e) for children and teens with autism who have severe self-injury or aggression that hasn't improved with other treatments. The therapy is given as a one-time injection into a specific brain area. The goal is to see if it reduces these dangerous behaviors.

Summary written for real people, not researchers, by Clin2.

Phase
Early Phase 1
Enrollment
6 people
Ages
7 years to 18 years
Study type
Interventional

Who can take part

  • You are between 7 and 18 years old.
  • You have a confirmed autism diagnosis (based on standard tests).
  • For at least 6 months, behavioral therapy has not helped your self-injury or aggression, or you could not do the therapy.
  • In the last 3 months, you have had repeated self-injury or aggressive behavior (like hitting, biting, or head-banging) that is moderate to severe.
  • You have tried at least one antipsychotic and one mood-stabilizer medication, but they did not work well or caused bad side effects, and you have been off these meds for at least 1 month.
  • You are willing to use birth control (if of childbearing age) from screening until a year after treatment.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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