NCT02947880

Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology

Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology : Multicenter and Double Blind-study With Randomized Parallel Group, Against Placebo.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

During a previous therapeutic trial, investigators showed that the bumetanide improved significantly autism. This trial showed that a therapeutic response was obtained in 75% of cases. These first results were reinforced by a study led with adult patients for whom the eye tracking measurements as well as the functional MRI showed a diminution of the response time and a modification (amplification) of the cerebral response during an emotions recognition test. Finally, investigators confirmed the physiological mechanism behind the action of the bumetanide in a study in two mouse models of autism.

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Bumetanide	For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
DRUG	Placebo	For the patient of 25kg and more the placebo is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2016-10-28
• Last updated: 2021-06-02