Status:
COMPLETED
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Huntington's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10 in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).
Detailed Description
secondary objectives: 1. To assess the change from baseline to 20 weeks on biomarkers of oxidative stress (8OHdG and 8OHrG) and DNA repair mechanisms (OGG1) in pre-manifest participants treated with ...
Eligibility Criteria
Inclusion
- Participants will be positive for the CAGn expansion in the Huntingtin gene (\>36 repeats) and be pre-manifest by virtue of scoring 3 or less on diagnostic confidence level (Question 17 of the UHDRS)
- Participants will have received genetic testing prior to enrollment through a standard pre-manifest testing protocol.
- 18 years of age or older.
- Concomitant medications are permitted with the exception of CoQ10, creatine \> 5g/day and warfarin.
Exclusion
- History of intolerability to CoQ10.
- CoQ10 use within 60 days prior to randomization.
- Unstable medical or psychiatric illness;
- Substance abuse within one year of the baseline visit.
- Pregnancy, breastfeeding or lack of reliable contraception in women of childbearing age.
- Subjects with known allergy to FD\&C #6 yellow food coloring.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00920699
Start Date
February 1 2010
End Date
March 1 2012
Last Update
September 25 2017
Active Locations (13)
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1
University of California Davis
Sacramento, California, United States, 95817
2
Colorado Neurological Institute
Englewood, Colorado, United States, 80120
3
University of Miami School of Medicine
Miami, Florida, United States, 33136
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30329