Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

NCT03715153 · clinicaltrials.gov ↗

PHASE3

Phase

TERMINATED

Status

211

Enrollment

OTHER

Sponsor class

Stopped The 6-month efficacy analysis did not show any significant difference between bumetanide versus placebo in the treatment of ASD in the overall studied population. No unexpected safety concerns were identified.

Conditions

Autism Spectrum Disorder (ASD)

Interventions

DRUG: BUMETANIDE (S95008) for week 0 - 26
DRUG: PLACEBO for week 0 - 26
DRUG: Open-Label BUMETANIDE (S95008) for weeks 26 - 52

Sponsor

Institut de Recherches Internationales Servier

Collaborators

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