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Role of Bumetanide in Treatment of Autism

Primary Purpose

Autism

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Bumetanide
Placebo
Sponsored by
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sherief Abd-ElsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bumetanide group

Placebo

Arm Description

Bumetanide a dose of 0.5 mg twice per day

Placebo twice daily

Outcomes

Primary Outcome Measures

Number of patients with improved CARS score
the patients with improved CARS score

Secondary Outcome Measures

Full Information

First Posted
February 19, 2021
Last Updated
February 19, 2021
Sponsor
Sherief Abd-Elsalam
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1. Study Identification

Unique Protocol Identification Number
NCT04766177
Brief Title
Role of Bumetanide in Treatment of Autism
Official Title
Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Role of bumetanide in Autism
Detailed Description
Role of Bumetanide in Treatment of Autism spectrum disorder in children

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bumetanide group
Arm Type
Experimental
Arm Description
Bumetanide a dose of 0.5 mg twice per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily
Intervention Type
Drug
Intervention Name(s)
Bumetanide
Other Intervention Name(s)
burinex
Intervention Description
bumetanide 0.5 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo treatment
Intervention Description
placebo tablets twice daily
Primary Outcome Measure Information:
Title
Number of patients with improved CARS score
Description
the patients with improved CARS score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with ASD diagnosed by CARS rating Scale⩾30. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Elagamy, Prof
Organizational Affiliation
Pediatrics Department- Kafr-Elsheikh University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abeer Salamah, Dr
Organizational Affiliation
Pediatrics Department- Kafr-Elsheikh University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Esraa Shaker, Msc
Organizational Affiliation
Pediatrics Department- Kafr-Elsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Ass. Prof.
Phone
00201009221243
Email
sheriefabdelsalam@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Bumetanide in Treatment of Autism

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