Overview

This trial is active, not recruiting.

Condition huntington's disease
Treatment coq10
Phase phase 2
Sponsor Huntington Study Group
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date February 2010
End date March 2012
Trial size 90 participants
Trial identifier NCT00920699, NIH grant: 1 R01 NS060118-01A1, PREQUEL-01.00

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
coq10 -Ubiquinone
Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
(Experimental)
All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
coq10 -Ubiquinone
Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
(Experimental)
All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
coq10 -Ubiquinone
Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.

Primary Outcomes

Measure
Tolerability: Ability to complete the study on the originally randomized treatment assignment.
time frame: 20 weeks

Secondary Outcomes

Measure
Additional Tolerability
time frame: 20 weeks
Safety (labs and clinical)
time frame: 20 weeks
Biomarkers (8OHdG/8OHrG and OGG1)
time frame: 20 weeks
CoQ10 Levels
time frame: 20 weeks
Clinical (UHDRS '99;FASRBE;IADL;BDI-II;C-SSRS)
time frame: 20 weeks
Feasibility (Enrollment rate;completing the study;visit and study med compliance)
time frame: 20 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease
Principal investigator Christopher A Ross, MD, PhD
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 600, 1200 or 2400 mg per day of CoQ10. 2. To assess the dose-response relationship between CoQ10 at dosages of 600, 1200 or 2400 mg per day and 8OHdG/8OHrG and OGG1. 3. To assess the serum levels of CoQ10 at 600, 1200 or 2400 mg in pre-manifest participants and their relationship to 8OHdG/8OHrG and OGG1. 4. To assess the feasibility of implementing a preventive therapeutic trial in a pre-manifest population. 5. To assess the utility and stability of clinical measures of HD, social relations, behavior and employment in a pre-manifest sample enrolled in a treatment trial.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Huntington Study Group.