Role of Bumetanide in Treatment of Autism

Overview

Role of bumetanide in Autism

Full Title of Study: “Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2030

Detailed Description

Role of Bumetanide in Treatment of Autism spectrum disorder in children

Interventions

  • Drug: Bumetanide
    • bumetanide 0.5 mg twice daily
  • Drug: Placebo
    • placebo tablets twice daily

Arms, Groups and Cohorts

  • Experimental: bumetanide group
    • Bumetanide a dose of 0.5 mg twice per day
  • Placebo Comparator: Placebo
    • Placebo twice daily

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with improved CARS score
    • Time Frame: 6 months
    • the patients with improved CARS score

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sherief Abd-Elsalam
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine – Tanta University
  • Overall Official(s)
    • Osama Elagamy, Prof, Principal Investigator, Pediatrics Department- Kafr-Elsheikh University
    • Abeer Salamah, Dr, Study Director, Pediatrics Department- Kafr-Elsheikh University
    • Esraa Shaker, Msc, Principal Investigator, Pediatrics Department- Kafr-Elsheikh University
  • Overall Contact(s)
    • Sherief Abd-Elsalam, ass. prof., 00201147773440, sheriefabdelsalam@yahoo.com

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