Trial record 2 of 3 for:    coenzyme Q10 and huntington

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Huntington Study Group:

Primary Outcome Measures:
  • Tolerability: Ability to complete the study on the originally randomized treatment assignment. [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: February 2010
Estimated Study Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
St. 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
Huntington Study Group
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:
No publications provided

Responsible Party: Christopher A. Ross, MD, PhD-Principal Investigator, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00920699     History of Changes
Other Study ID Numbers: PREQUEL-01.00, NIH grant: 1 R01 NS060118-01A1
Study First Received: June 9, 2009
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014