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Trial record 2 of 3 for:    Coenzyme Q10 huntington

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920699
First Posted: June 15, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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).

Condition Intervention Phase
Huntington's Disease Drug: CoQ10 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 %


Secondary Outcome Measures:
  • 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


Enrollment: 90
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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: 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.
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920699


Locations
United States, California
University of California Davis
Sacramento, California, United States, 95817
United States, Colorado
Colorado Neurological Institute
Englewood, Colorado, United States, 80120
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Hereditary Neurological Disease Centre (HNDC)
Wichita, Kansas, United States, 67206
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Albany Medical College
Albany, New York, United States, 12208
University of Rochester
Rochester, New York, United States, 14618
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Johns Hopkins University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Christopher A Ross, MD, PhD Johns Hopkins University
Principal Investigator: Kevin M Biglan, MD, MPH University of Rochester
  More Information

Additional Information:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00920699     History of Changes
Other Study ID Numbers: PREQUEL-01.00
NIH grant: 1 R01 NS060118-01A1
First Submitted: June 9, 2009
First Posted: June 15, 2009
Results First Submitted: August 25, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Huntington Disease
Coenzyme Q10
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins