NCT04216186

Brief Summary

Role of Coenzyme Q in ADHD in Children

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
56mo left

Started Nov 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Nov 2018Dec 2030

Study Start

First participant enrolled

November 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

12.1 years

First QC Date

December 29, 2019

Last Update Submit

December 29, 2019

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improved CONNERS scale

    The number of patients with improved CONNERS scale

    6 months

Study Arms (2)

Atomoxetine and Coenzyme Q

ACTIVE COMPARATOR

Atomoxetine and Coenzyme Q

Drug: AtomoxetineDrug: Coenzyme Q

Placebo and Atomoxetine

PLACEBO COMPARATOR

Placebo and Coenzyme Q

Drug: Coenzyme Q

Interventions

AtomoxetineDRUG

Atomoxetine once daily

Also known as: atomox
Atomoxetine and Coenzyme Q
Coenzyme QDRUG

Coenzyme Q once daily

Atomoxetine and Coenzyme QPlacebo and Atomoxetine

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with ADHD

You may not qualify if:

  • Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34819012DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine HydrochlorideUbiquinone

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsBenzoquinonesQuinonesCoenzymesEnzymes and Coenzymes

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 2, 2020

Study Start

November 1, 2018

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)