Plain-English translation of NCT07642661 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing (a naturally occurring form of vitamin B) to see if it can help reduce symptoms in young children with autism spectrum disorder. Researchers believe that some children with autism may have difficulty getting enough of this B-vitamin into their brains, which could affect development and behavior. This study will compare the medication to a placebo (a dummy pill with no active ingredient) to see if the treatment is safe and actually helps.
Right now, there are no medications that treat the core symptoms of autism itself—only some of the difficult behaviors that sometimes come with it. Those existing medications can have unwanted side effects like weight gain and sleepiness. This research is exploring whether this medication might be a safer option that could help more of the core autism symptoms and related issues like irritability or sleep problems.
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If you join, your child would receive either the medication or a placebo for 9 weeks while researchers monitor how well it works and whether there are any side effects. After that first phase, all children would then receive the medication at one of two different doses for another 8 weeks. Your child would continue any other treatments they're already taking, and you'd attend visits where researchers would assess your child's behavior and development using standard rating scales.
AI-generated summary from trial data · Jul 2, 2026 · Not medical advice
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