ADHDPhase 3NCT04216186
Role of Coenzyme Q in ADHD in Children
A Phase 3 study testing Atomoxetine and Coenzyme Q in people with ADHD, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Role of Coenzyme Q in ADHD in Children Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- ADHD
- What is being tested?
- Atomoxetine and Coenzyme Q
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with ADHD
Who cannot join
- Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.
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 Coenzyme Q in Treatment of Attention Deficit Hyperactivity Disorder in Children
Role of Coenzyme Q in ADHD in Children
Read the detailed description
Role of Coenzyme Q in ADHD in Children: will it add a benefit?
- Conditions
- ADHD
- Being tested
- Atomoxetine, Coenzyme Q
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Also called atomox
Atomoxetine once daily
Coenzyme QDrug
Coenzyme Q once daily
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine and Coenzyme Q | Active comparator | Atomoxetine and Coenzyme Q Receives: Drug: Atomoxetine; Drug: Coenzyme Q |
| Placebo and Atomoxetine | Placebo comparator | Placebo and Coenzyme Q Receives: Drug: Coenzyme Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved CONNERS scale
The number of patients with improved CONNERS scale
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 posted2 Jan 2020
- Study start1 Nov 2018
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 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
- Fatma G. Abdelkader, Msc, Principal investigator, Pediatrics department - Kafr Elsheikh UniversityOsama A Elagamy, Prof., Principal investigator, Pediatrics department - Kafr Elsheikh UniversityAbeer Salamah, Lecturer, Principal investigator, Pediatrics department - Kafr Elsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216186
- Sponsor's protocol ID
- abeer salamah
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamal F, El Agami O, Salamah A. Coenzyme Q10 in the Treatment of Attention Deficit Hyperactivity Disorder in Children: A Randomized Controlled Trial. CNS Neurol Disord Drug Targets. 2022;21(8):717-723. doi: 10.2174/1871527320666211124093345.
PubMed 34819012
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Coenzyme Q in Treatment of Attention Deficit Hyperactivity Disorder in Children
- ClinicalTrials.gov ID
- NCT04216186
- Acronym / sponsor ID
- abeer salamah
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 2 Jan 2020 (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 Coenzyme Q in ADHD in Children
Detailed description
Role of Coenzyme Q in ADHD in Children: will it add a benefit?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine and Coenzyme Q | Active comparator | Drug: Atomoxetine, Drug: Coenzyme QAtomoxetine and Coenzyme Q |
| Placebo and Atomoxetine | Placebo comparator | Drug: Coenzyme QPlacebo and Coenzyme Q |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with ADHD
Key exclusion criteria (1 listed)
- Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.
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 |
|---|---|---|
| AtomoxetineAlso: atomoxAtomoxetine once daily | Drug | Atomoxetine and Coenzyme Q |
| Coenzyme QCoenzyme Q once daily | Drug | Atomoxetine and Coenzyme Q, Placebo and Atomoxetine |
Primary outcome
Number of patients with improved CONNERS scale
Time frame: 6 months
The number of patients with improved CONNERS scale
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 2 Jan 2020.
- Derived from this study: PubMed 34819012Gamal F, El Agami O, Salamah A. Coenzyme Q10 in the Treatment of Attention Deficit Hyperactivity Disorder in Children: A Randomized Controlled Trial. CNS Neurol Disord Drug Targets. 2022;21(8):717-723. doi: 10.2174/1871527320666211124093345.
- 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.
Fatma G. Abdelkader, Msc principal investigator
Pediatrics department - Kafr Elsheikh University
Osama A Elagamy, Prof. principal investigator
Pediatrics department - Kafr Elsheikh University
Abeer Salamah, Lecturer 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 Atomoxetine and Coenzyme Q in people with ADHD, 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 1 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 2 Jan 2020. 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 CONNERS scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216186, which also lists 1 linked publication.
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 2 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.