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

Completed · Phase 2 · Has a placebo group

Conditions studied: Huntington's Disease

In brief

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).

Key facts

Study ID

NCT00920699

Run by

Johns Hopkins University

People needed

90

Starts

2010-02-01

Expected to finish

2012-03-01

Last updated by the study team

2017-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California Davis — Sacramento, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Hereditary Neurological Disease Centre (HNDC) — Wichita, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Albany Medical College — Albany, New York, United States
• University of Rochester — Rochester, New York, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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