Role of Bumetanide in Treatment of Autism

NCT ID: NCT04766177

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2030-12-01

Brief Summary

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Role of bumetanide in Autism

Detailed Description

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Role of Bumetanide in Treatment of Autism spectrum disorder in children

Conditions

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bumetanide group

Bumetanide a dose of 0.5 mg twice per day

Group Type EXPERIMENTAL

Bumetanide

Intervention Type DRUG

bumetanide 0.5 mg twice daily

Placebo

Placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo tablets twice daily

Interventions

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Bumetanide

bumetanide 0.5 mg twice daily

Intervention Type DRUG

Placebo

placebo tablets twice daily

Intervention Type DRUG

Other Intervention Names

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burinex Placebo treatment

Eligibility Criteria

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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).
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Osama Elagamy, Prof

Role: PRINCIPAL_INVESTIGATOR

Pediatrics Department- Kafr-Elsheikh University

Abeer Salamah, Dr

Role: STUDY_DIRECTOR

Pediatrics Department- Kafr-Elsheikh University

Esraa Shaker, Msc

Role: PRINCIPAL_INVESTIGATOR

Pediatrics Department- Kafr-Elsheikh University

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-Elsalam, Ass. Prof.

Role: primary

00201009221243

Other Identifiers

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autism

Identifier Type: -

Identifier Source: org_study_id

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