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

Huntington's Disease Clinical Trial

— PREQUEL  

Official title:

A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920699
• Other study ID #: PREQUEL-01.00
• Secondary ID: NIH grant: 1 R01
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2009
• Last updated: August 25, 2017
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Drug:
• CoQ10
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.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Miami School of Medicine	Miami	Florida
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Rochester	Rochester	New York
United States	University of California Davis	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	Hereditary Neurological Disease Centre (HNDC)	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.	No dosage modifications, reported as a %	20 weeks
Secondary	8OHdG Levels	ng/ml. Negative value signifies an decrease in 8OHdG levels	change from baseline to 20 weeks
Secondary	CoQ10 Levels	ng/ml	change from baseline to 20 weeks

External Links

•   Huntington Study Group