NCT03715153

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

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

Detailed description

The present study (CL3-95008-002) was performed in children from 2 to less than 7 years old presenting with ASD. A 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg BID were assessed versus placebo. This double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg twice daily in which long term safety was evaluated.

Conditions

• Autism Spectrum Disorder (ASD)

Interventions

Type	Name	Description
DRUG	BUMETANIDE (S95008) for week 0 - 26	Oral solution dosed at 0.5 mg/mL Taken twice daily.
DRUG	PLACEBO for week 0 - 26	Oral solution Taken twice daily.
DRUG	Open-Label BUMETANIDE (S95008) for weeks 26 - 52	Oral solution dosed at 0.5 mg/mL Taken twice daily.

Timeline

• Start date: 2018-10-04
• Primary completion: 2021-10-26
• Completion: 2021-10-26
• First posted: 2018-10-23
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

50 sites across 12 countries: United States, Australia, Brazil, Czechia, France, Hungary, Italy, Poland, Portugal, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study