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| Sponsor: | Huntington Study Group |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Huntington Study Group |
| ClinicalTrials.gov Identifier: | NCT00920699 |
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 II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Dose Comparison 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 |
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
600 mg per day of CoQ10: Experimental
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.
|
|
1200 mg per day of CoQ10: Experimental
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.
|
|
2400 mg per day of CoQ10: Experimental
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.
|
secondary objectives:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Elaine M Julian-Baros, BS | (585) 273-2879 | elaine.julianbaros@ctcc.rochester.edu |
| United States, California | |
| University of California Davis | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Terry Tempkin, RCN, MSN 916-734-6278 teresa.tempkin@ucdmc.ucdavis.edu | |
| Principal Investigator: Vicki L Wheelock, MD | |
| United States, Colorado | |
| Colorado Neurological Institute | Recruiting |
| Englewood, Colorado, United States, 80120 | |
| Contact: Diane Erickson, RN 303-762-6674 derickson@thecni.org | |
| Principal Investigator: Vicki Segro, MSN, C-ANP | |
| United States, Georgia | |
| Emory University School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: Cathy Wood-Siverio, MS 404-728-4782 cwoodsi@emory.edu | |
| Principal Investigator: Randi Jones, PhD | |
| United States, Indiana | |
| Indiana University School of Medicine | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: JoAnn Belden, RN, LPN 317-278-0868 jbelden@iupui.edu | |
| Contact: Katie Price 317-274-3989 kpkeller@iupui.edu | |
| Principal Investigator: Joanne Wojcieszek, MD | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Nancy Hale, BS, RN 319-353-4537 nancy-hale@uiowa.edu | |
| Principal Investigator: Leigh Beglinger, PhD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Nadine Yoritomo, RN 410-614-9254 nyorito1@jhmi.edu | |
| Principal Investigator: Margolis L Russell, MD | |
| United States, Minnesota | |
| Hennepin County Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Dawn Radtke, RN 612-873-2943 dawn.radtke@yahoo.com | |
| Principal Investigator: Martha Nance, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Melissa Ammel 314-747-3470 ammelm@neuro.wustl.edu | |
| Principal Investigator: Susan Criswell, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14618 | |
| Contact: Amy Chesire, MD 585-341-7519 amy.chesire@ctcc.rochester.edu | |
| Principal Investigator: Frederick Marshall, M.D. | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Christine Hunter, RN, CCRC 713-798-3951 chunter@bcm.tmc.edu | |
| Principal Investigator: William Ondo, MD | |
| Principal Investigator: | Christopher A Ross, MD, PhD | Johns Hopkins University |
| Principal Investigator: | Kevin M Biglan, MD, MPH | University of Rochester |
More Information
| Responsible Party: | Johns Hopkins University School of Medicine ( Christopher A. Ross, MD, PhD-Principal Investigator ) |
| 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: | May 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Huntington Disease 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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Coenzyme Q10 Ubiquinone Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vitamins |