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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Huntington Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Huntington Study Group
ClinicalTrials.gov Identifier:
NCT00920699
First received: June 9, 2009
Last updated: March 28, 2012
Last verified: March 2012

June 9, 2009
March 28, 2012
February 2010
March 2012   (final data collection date for primary outcome measure)
Tolerability: Ability to complete the study on the originally randomized treatment assignment. [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00920699 on ClinicalTrials.gov Archive Site
  • Additional Tolerability [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Safety (labs and clinical) [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Biomarkers (8OHdG/8OHrG and OGG1) [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • CoQ10 Levels [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Clinical (UHDRS '99;FASRBE;IADL;BDI-II;C-SSRS) [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Feasibility (Enrollment rate;completing the study;visit and study med compliance) [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease

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).

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Huntington's Disease
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
June 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00920699
PREQUEL-01.00, NIH grant: 1 R01 NS060118-01A1
Yes
Christopher A. Ross, MD, PhD-Principal Investigator, Johns Hopkins University School of Medicine
Huntington Study Group
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Christopher A Ross, MD, PhD Johns Hopkins University
Principal Investigator: Kevin M Biglan, MD, MPH University of Rochester
Huntington Study Group
March 2012

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