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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00920699
Date of registration: 09/06/2009
Prospective Registration: Yes
Primary sponsor: Johns Hopkins University
Public title: Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL) PREQUEL
Scientific title: A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease
Date of first enrolment: February 2010
Target sample size: 90
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00920699
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Christopher A Ross, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Johns Hopkins University
Name:     Kevin M Biglan, MD, MPH
Address: 
Telephone:
Email:
Affiliation:  University of Rochester
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Huntington's Disease
Intervention(s)
Drug: CoQ10
Primary Outcome(s)
Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment. [Time Frame: 20 weeks]
Secondary Outcome(s)
8OHdG Levels [Time Frame: change from baseline to 20 weeks]
CoQ10 Levels [Time Frame: change from baseline to 20 weeks]
Secondary ID(s)
NIH grant: 1 R01 NS060118-01A1
PREQUEL-01.00
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Neurological Disorders and Stroke (NINDS)
Ethics review
Results
Results available: Yes
Date Posted: 25/09/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00920699
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