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A Study to Evaluate Ketamine for the Treatment of Rett Syndrome

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Double-blind, placebo-controlled crossover trial (n=23) assessing oral ketamine given twice daily for 5 days (cohort doses 0.75 mg/kg and 1.5 mg/kg) vs placebo in females aged 6–12 with Rett syndrome.

Details

Sequential, ascending-dose study with up to four cohorts; each participant receives a 5-day BID course of cohort-specified oral ketamine and a 5-day course of matched placebo in randomised, double-blind crossover order with 2-week safety follow-up after each period.

Primary assessments include safety and tolerability (AEs, vitals, physical exam, concomitant medications); exploratory efficacy via physician and caregiver questionnaires and continuous wearable at-home biosensor data.

Topics:Autism Spectrum Disorder (ASD)

Registry

Registry linkNCT03633058