ClinicalTrials.gg
Sign In
RecruitingNCT04766177Updated Feb 23, 2021

Role of Bumetanide in Treatment of Autism

A Phase 3 interventional study of Bumetanide and Placebo in Autism, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-02-23.

Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2021; still recruiting 5 years 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
3 Years to 12 Years
Sex
All
01

Study summary

Role of bumetanide in Autism

Read the detailed description

Role of Bumetanide in Treatment of Autism spectrum disorder in children

02

Conditions studied

  • Autism

Browse trials for

03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 80 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Sherief Abd-Elsalam is the lead sponsor of 50 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or abnormalities and syndromatic children(Rett).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    bumetanide group

    Bumetanide a dose of 0.5 mg twice per day

    Drug: Bumetanide

  • Placebo comparator
    Placebo

    Placebo twice daily

    Drug: Placebo

Interventions

  • DrugBumetanide

    bumetanide 0.5 mg twice daily

    Also known as: burinex

  • DrugPlacebo

    placebo tablets twice daily

    Also known as: Placebo treatment

06

What researchers measure

Primary outcomes

  1. Number of patients with improved CARS score

    the patients with improved CARS score

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Dec 2030, 119 months after the start.

Of 15 phase 3 interventional studies under Autistic Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 48. This study's planned 119 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2021
First posted
Feb 23, 2021
StartActual
Jan 1, 2021
Primary completionEst.
Dec 1, 2030
CompletionEst.
Dec 1, 2030
Last update
Feb 23, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04766177
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Sponsor-investigator
First posted
Feb 23, 2021
Start date
Jan 1, 2021
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 1, 2030 (estimated)
Last update
Feb 23, 2021

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Osama Elagamy, Prof
principal investigator · Pediatrics Department- Kafr-Elsheikh University
Abeer Salamah, Dr
study director · Pediatrics Department- Kafr-Elsheikh University
Esraa Shaker, Msc
principal investigator · Pediatrics Department- Kafr-Elsheikh University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Bumetanide

Other studies in this condition

Autistic Disorder →

Other studies from this sponsor

Sherief Abd-Elsalam

Start the discussion