Role of Bumetanide in Treatment of Autism | NCT04766177

Studies
Role of Bumetanide in Treatment of Autism

NCT04766177

Sponsor

Sherief Abd-Elsalam

Status

Recruiting

Last Update Posted

Feb 23, 2021Actual

Enrollment

80Estimated

Phase

Phase 3

Conditions

Autism

Interventions

Bumetanide
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 1, 2030Estimated

Completion Date

Dec 1, 2030Estimated

First Submitted Date

Feb 19, 2021

First Submission Date that Met QC Criteria

Feb 19, 2021

First Posted Date

Feb 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2021

Last Update Posted Date

Feb 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bumetanide group	Experimental	Bumetanide a dose of 0.5 mg twice per day	Drug: Bumetanide
Placebo	Placebo Comparator	Placebo twice daily	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bumetanide	Drug	bumetanide 0.5 mg twice daily	bumetanide group	burinex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with improved CARS score	the patients with improved CARS score	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, ass. prof.	Contact	00201147773440		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Osama Elagamy, Prof	Pediatrics Department- Kafr-Elsheikh University	Principal Investigator
Abeer Salamah, Dr	Pediatrics Department- Kafr-Elsheikh University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002034	Bumetanide

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D062368	meta-Aminobenzoates

Browse Leaves

Not provided

Browse Branches

Not provided