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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00920699 |
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Date of registration:
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09/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
PREQUEL |
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Scientific title:
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A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00920699 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Kevin M Biglan, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Rochester |
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Name:
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Christopher A Ross, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Huntington's Disease
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Intervention(s)
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Drug: CoQ10
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Primary Outcome(s)
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Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.
[Time Frame: 20 weeks]
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Secondary Outcome(s)
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8OHdG Levels
[Time Frame: change from baseline to 20 weeks]
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CoQ10 Levels
[Time Frame: change from baseline to 20 weeks]
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Secondary ID(s)
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NIH grant: 1 R01 NS060118-01A1
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PREQUEL-01.00
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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