- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216186
Role of Coenzyme Q in ADHD in Children
December 29, 2019 updated by: Sherief Abd-Elsalam
Role of Coenzyme Q in Treatment of Attention Deficit Hyperactivity Disorder in Children
Role of Coenzyme Q in ADHD in Children
Study Overview
Detailed Description
Role of Coenzyme Q in ADHD in Children: will it add a benefit?
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt
- Recruiting
- Sherief Abd-Elsalam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with ADHD
Exclusion Criteria:
- Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Atomoxetine and Coenzyme Q
|
Atomoxetine once daily
Other Names:
Coenzyme Q once daily
|
PLACEBO_COMPARATOR: Placebo and Atomoxetine
Placebo and Coenzyme Q
|
Coenzyme Q once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with improved CONNERS scale
Time Frame: 6 months
|
The number of patients with improved CONNERS scale
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatma G. Abdelkader, Msc, Pediatrics department - Kafr Elsheikh University
- Principal Investigator: Osama A Elagamy, Prof., Pediatrics department - Kafr Elsheikh University
- Principal Investigator: Abeer Salamah, Lecturer, Pediatrics department - Kafr Elsheikh University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2018
Primary Completion (ANTICIPATED)
December 1, 2030
Study Completion (ANTICIPATED)
December 1, 2030
Study Registration Dates
First Submitted
December 29, 2019
First Submitted That Met QC Criteria
December 29, 2019
First Posted (ACTUAL)
January 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 29, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- abeer salamah
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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