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Mitochondrial Complex I Dysfunction in PWS

NCT03831425 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-06-18

No results posted yet for this study

Summary

Prader-Willi Syndrome (PWS) is characterized by profound infantile hypotonia, growth delay, cognitive impairment, muscle weakness and exercise intolerance. Studies have suggested that a defect in energy metabolism, yet to be clarified, may be involved in its pathogenesis. Many PWS patients have received Coenzyme Q10, but the rationale for this and objective impact on cellular metabolism has not been clarified.

Conditions

Interventions

DIETARY_SUPPLEMENT

Coenzyme Q10

6 week trial of either treatment with CoenzymeQ.

OTHER

Placebo

6 week trial of either treatment with Placebo

Sponsors & Collaborators

  • Foundation for Prader-Willi Research

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Ingrid Tein, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831425 on ClinicalTrials.gov