Role of Bumetanide in Treatment of Autism

Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children

Role of bumetanide in Autism

Study Overview

• Status: Recruiting
• Conditions: Autism
• Intervention / Treatment: Drug: Placebo; Drug: Bumetanide

Detailed Description

Role of Bumetanide in Treatment of Autism spectrum disorder in children

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Sherief Abd-Elsalam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All patients with ASD diagnosed by CARS rating Scale⩾30.
2. Age of patients range between (3-12) years.

Exclusion Criteria:

• Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or electrocardiogram abnormalities and syndromatic children(Rett).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo twice daily	Drug: Placebo; placebo tablets twice daily; Other Names: Placebo treatment
Experimental: bumetanide group; Bumetanide a dose of 0.5 mg twice per day	Drug: Bumetanide; bumetanide 0.5 mg twice daily; Other Names: burinex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with improved CARS score	the patients with improved CARS score	6 months

Collaborators and Investigators

• Sponsor: Sherief Abd-Elsalam
• Investigators: Principal Investigator: Osama Elagamy, Prof, Pediatrics Department- Kafr-Elsheikh University; Study Director: Abeer Salamah, Dr, Pediatrics Department- Kafr-Elsheikh University; Principal Investigator: Esraa Shaker, Msc, Pediatrics Department- Kafr-Elsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Bumetanide
• Other Study ID Numbers: AUTISM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No