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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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ClinicalTrials.gov Identifier: NCT00920699
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE June 9, 2009
First Posted Date  ICMJE June 15, 2009
Results First Submitted Date  ICMJE August 25, 2017
Results First Posted Date  ICMJE September 25, 2017
Last Update Posted Date September 25, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment. [ Time Frame: 20 weeks ]
No dosage modifications, reported as a %
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
Tolerability: Ability to complete the study on the originally randomized treatment assignment. [ Time Frame: 20 weeks ]
Change History Complete list of historical versions of study NCT00920699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • 8OHdG Levels [ Time Frame: change from baseline to 20 weeks ]
    ng/ml. Negative value signifies an decrease in 8OHdG levels
  • CoQ10 Levels [ Time Frame: change from baseline to 20 weeks ]
    ng/ml
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
Official Title  ICMJE A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease
Brief 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).
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE 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.
Other Names:
  • -Ubiquinone
  • -coenzyme Q10
Study Arms  ICMJE
  • Experimental: 600 mg per day of CoQ10
    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.
    Intervention: Drug: CoQ10
  • Experimental: 1200 mg per day of CoQ10
    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.
    Intervention: Drug: CoQ10
  • Experimental: 2400 mg per day of CoQ10
    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.
    Intervention: Drug: CoQ10
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2009)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920699
Other Study ID Numbers  ICMJE PREQUEL-01.00
NIH grant: 1 R01 NS060118-01A1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Christopher A Ross, MD, PhD Johns Hopkins University
Principal Investigator: Kevin M Biglan, MD, MPH University of Rochester
PRS Account Johns Hopkins University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP