NCT04766177

Brief Summary

Role of bumetanide in Autism

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
56mo left

Started Jan 2021

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jan 2021Dec 2030

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

9.9 years

First QC Date

February 19, 2021

Last Update Submit

February 19, 2021

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improved CARS score

    the patients with improved CARS score

    6 months

Study Arms (2)

bumetanide group

EXPERIMENTAL

Bumetanide a dose of 0.5 mg twice per day

Drug: Bumetanide

Placebo

PLACEBO COMPARATOR

Placebo twice daily

Drug: Placebo

Interventions

BumetanideDRUG

bumetanide 0.5 mg twice daily

Also known as: burinex
bumetanide group
PlaceboDRUG

placebo tablets twice daily

Also known as: Placebo treatment
Placebo

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Interventions

Bumetanide

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic Chemicalsmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Osama Elagamy, Prof

    Pediatrics Department- Kafr-Elsheikh University

    PRINCIPAL INVESTIGATOR

  • Abeer Salamah, Dr

    Pediatrics Department- Kafr-Elsheikh University

    STUDY DIRECTOR

  • Esraa Shaker, Msc

    Pediatrics Department- Kafr-Elsheikh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 23, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)