NCT03715166

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 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: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The present study (CL3-95008-001) was performed in children and adolescents from 7 to less than 18 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 BID in which long term safety was evaluated.

Conditions

• Autism Spectrum Disorder (ASD)

Interventions

Type	Name	Description
DRUG	Bumetanide Oral Solution	Oral Solution dosed at 0.5mg/mL Taken twice daily
DRUG	Placebo	Oral Solution Taken twice daily

Timeline

• Start date: 2018-09-24
• Primary completion: 2021-09-13
• Completion: 2021-09-13
• First posted: 2018-10-23
• Last updated: 2024-07-25

Locations

45 sites across 10 countries: Brazil, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom