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Role of Bumetanide in Treatment of Autism

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT04766177
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
119
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Role of bumetanide in Autism

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Role of Bumetanide in Treatment of Autism spectrum disorder in children

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

Arm Intervention/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

    		•
    Placebo Comparator: Placebo

    Placebo twice daily

    Drug: Placebo
    placebo tablets twice daily
    Other Names:
  • Placebo treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with improved CARS score [6 months]

      the patients with improved CARS score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. All patients with ASD diagnosed by CARS rating Scaleā©¾30.

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Tanta Egypt

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04766177
    Other Study ID Numbers:
    • autism
    First Posted:
    Feb 23, 2021
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Autistic Disorder
    Bumetanide

    Study Results

    No Results Posted as of Feb 23, 2021