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Dietary Supplement

CoQ10 for Prader-Willi Syndrome

Phase 2
Waitlist Available
Led By Ingrid Tein, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight > 35.0 kg
Patients with genetically confirmed PWS aged 13 to 18 years (n=14)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8 (after 6 weeks on study drug or placebo), [6 week washout], week 20 (after 6 weeks study drug or placebo)
Awards & highlights

Study Summary

This trial aimed to assess the effect of CoQ10 on PWS patients' cellular energy metabolism.

Who is the study for?
This trial is for teens aged 13-18 with genetically confirmed Prader-Willi Syndrome, weighing over 35 kg and in good health. They must be able to do exercise tests and take oral meds. Girls must use effective birth control, and boys need to ensure contraception during the study.Check my eligibility
What is being tested?
The trial is testing Coenzyme Q10 against a placebo in patients with PWS to see if it improves muscle weakness and energy metabolism issues associated with the syndrome. Participants will either receive CoQ10 or a placebo without knowing which one they are taking.See study design
What are the potential side effects?
While not specified here, common side effects of Coenzyme Q10 may include upset stomach, loss of appetite, nausea, vomiting, diarrhea; allergic reactions can occur but are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh more than 35 kilograms.
Select...
I am between 13 and 18 years old with confirmed Prader-Willi Syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8 (after 6 weeks on study drug or placebo), [6 week washout], week 20 (after 6 weeks study drug or placebo)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 (after 6 weeks on study drug or placebo), [6 week washout], week 20 (after 6 weeks study drug or placebo) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Three minute step test
Secondary outcome measures
6 Minute walk test
Childhood Health Assessment Questionnaire (CHAQ)
Hand Grip Test
+6 more
Other outcome measures
Magnetic Resonance Spectroscopy
Oxygen
Ergometry

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Coenzyme QExperimental Treatment1 Intervention
Each patient will be asked to take part in a 6 wk trial of pharmaceutical grade CoQ10 and will be randomly assigned to a start time. There will be a 6 wk washout period between treatment and placebo arms. At baseline, if this is the first arm, testing will include determination of muscle function based on our 3 min step test, muscle power (maximal jump, handgrip), strength (Queens' Square), endurance (6MWT), fatigue (PedsQL fatigue scale), physical activity level (3DPAR), attention (ADHDT scale), cognition (MoCA), physical function (CHAQ).and quality of life (PedQL). Following the 6 wk CoQ10 trial, testing will include repeat determination of all of the above as well as determination of total aerobic capacity (maximum cycle ergometry) and muscle metabolism (31P-MRS ergometry).
Group II: PlaceboPlacebo Group1 Intervention
Each patient will be asked to take part in a 6 wk trial of placebo and will be randomly assigned to a start time. There will be a 6 wk washout period between treatment and placebo arms. At baseline, if this is the first arm, testing will include determination of muscle function based on our 3 min step test, muscle power (maximal jump, handgrip), strength (Queens' Square), endurance (6MWT), fatigue (PedsQL fatigue scale), physical activity level (3DPAR), attention (ADHDT scale), cognition (MoCA), physical function (CHAQ).and quality of life (PedQL). Following the 6 wk placebo trial, testing will include repeat determination of all of the above as well as determination of total aerobic capacity (maximum cycle ergometry) and muscle metabolism (31P-MRS ergometry).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coenzyme Q10
2016
Completed Phase 4
~1190

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
692 Previous Clinical Trials
6,946,586 Total Patients Enrolled
2 Trials studying Prader-Willi Syndrome
58 Patients Enrolled for Prader-Willi Syndrome
Foundation for Prader-Willi ResearchOTHER
13 Previous Clinical Trials
1,174 Total Patients Enrolled
12 Trials studying Prader-Willi Syndrome
994 Patients Enrolled for Prader-Willi Syndrome
Ingrid Tein, MDPrincipal InvestigatorThe Hospital for Sick Children
2 Previous Clinical Trials
37 Total Patients Enrolled

Media Library

Coenzyme Q10 (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03831425 — Phase 2
Prader-Willi Syndrome Research Study Groups: Coenzyme Q, Placebo
Prader-Willi Syndrome Clinical Trial 2023: Coenzyme Q10 Highlights & Side Effects. Trial Name: NCT03831425 — Phase 2
Coenzyme Q10 (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03831425 — Phase 2
~0 spots leftby Jun 2024
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