Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huntington Study Group; Johns Hopkins University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Coenzyme Q10; Ubiquinone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.