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
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