AutismPhase 3NCT04766177
Role of Bumetanide in Treatment of Autism
A Phase 3 study testing Bumetanide in people with Autism, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Role of bumetanide in Autism Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- Bumetanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients with ASD diagnosed by CARS rating Scale⩾30.
- Age of patients range between (3-12) years.
Who cannot join
- Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or electrocardiogram abnormalities and syndromatic children(Rett).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam, Ass. Prof., 00201009221243, sheriefabdelsalam@yahoo.com
About this study
Official title: Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children
Role of bumetanide in Autism
Read the detailed description
Role of Bumetanide in Treatment of Autism spectrum disorder in children
- Conditions
- Autism
- Being tested
- Bumetanide, Placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BumetanideDrug
Also called burinex
bumetanide 0.5 mg twice daily
PlaceboDrug
Also called Placebo treatment
placebo tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| bumetanide group | Experimental | Bumetanide a dose of 0.5 mg twice per day Receives: Drug: Bumetanide |
| Placebo | Placebo comparator | Placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved CARS score
the patients with improved CARS score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Osama Elagamy, Prof, Principal investigator, Pediatrics Department- Kafr-Elsheikh UniversityAbeer Salamah, Dr, Study director, Pediatrics Department- Kafr-Elsheikh UniversityEsraa Shaker, Msc, Principal investigator, Pediatrics Department- Kafr-Elsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766177
- Sponsor's protocol ID
- autism
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children
- ClinicalTrials.gov ID
- NCT04766177
- Acronym / sponsor ID
- autism
- Conditions
- Autism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Role of bumetanide in Autism
Detailed description
Role of Bumetanide in Treatment of Autism spectrum disorder in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bumetanide group | Experimental | Drug: BumetanideBumetanide a dose of 0.5 mg twice per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All patients with ASD diagnosed by CARS rating Scale⩾30.
- Age of patients range between (3-12) years.
Key exclusion criteria (1 listed)
- Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or electrocardiogram abnormalities and syndromatic children(Rett).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BumetanideAlso: burinexbumetanide 0.5 mg twice daily | Drug | bumetanide group |
| PlaceboAlso: Placebo treatmentplacebo tablets twice daily | Drug | Placebo |
Primary outcome
Number of patients with improved CARS score
Time frame: 6 months
the patients with improved CARS score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bumetanide in people with Autism, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improved CARS score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.