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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 belowSelect...
I weigh more than 35 kilograms.
Select...
I am between 13 and 18 years old with confirmed Prader-Willi Syndrome.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
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 moreOther 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
686 Previous Clinical Trials
6,944,779 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart disease with heart failure.You are allergic to gelatin.I have diabetes.I have a long-term lung condition that is not asthma.I weigh more than 35 kilograms.I am currently taking CoQ10 supplements.You are unable to digest lactose.You have metal in your body that can't be in the MRI machine.I can take pills by mouth.You have used cannabis in the past six months.I have a bleeding disorder.I am between 13 and 18 years old with confirmed Prader-Willi Syndrome.I have thyroid disease or am on thyroid medication.I have a skin condition.You are currently taking part in another research study or using a new treatment.Your lab tests from the screening show important health issues.I have liver disease or a blockage in my bile duct.You cannot do exercise tests.You have smoked or used tobacco in the last 6 months.I am on medication for heart rhythm, blood pressure, or heart failure.I am a man who can father children and will use contraception during and 8 weeks after the study.I have a stomach disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Coenzyme Q
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are included in the scope of this research?
"Affirmative. According to the information published on clinicaltrials.gov, this study is actively recruiting volunteers as of August 3rd 2022; it was first posted in October 18th 2022 and will involve 14 individuals from single site."
Answered by AI
Is this medical experiment currently seeking participants?
"The records available on clinicaltrials.gov signify that this trial is actively seeking participants and has been since October 18th, 2022. The most recent edits to the study were made August 3rd, 2022."
Answered by AI
Has Coenzyme Q10 received governmental sanction to be used as a therapeutic agent?
"Our assessment of Coenzyme Q10's safety was a 2 due to the Phase 2 nature of this trial. Although there is evidence that it may be safe, no data exists that confirms its efficacy."
Answered by AI
Does this clinical trial allow me to participate?
"To participate in this study, those with Royer Syndrome between the ages of 13 and 18 are encouraged to apply. Currently, 14 spots remain open for enrolment."
Answered by AI
Is the age restriction for this clinical trial above fifty-five?
"Candidates for this medical trial must be aged between 13 and 18. Of the total 2,360 studies available, 376 are specifically tailored to younger patients while 984 cater to those over 65 years of age."
Answered by AI
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