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  PREQUEL - no longer recruiting research participants

Study in PRE-manifest Huntington’s disease of coenzyme Q10 (UbiquinonE) Leading to preventive trials 

On February 13, 2009 the Huntington Study Group (HSG) received funding from the National Institutes of Health (NIH) to study the safety and tolerability of coenzyme Q10 in pre-manifest Huntington disease (PREQUEL).

Under the direction of Christopher A. Ross, MD, PhD, Principal Investigator from Johns Hopkins University and Kevin M. Biglan, MD, MPH, Co-Investigator from University of Rochester, the PREQUEL study will be enrolling 90 study volunteers and is conducted at 10 institutions throughout the United States.  Below we have included a study outline along with contact information for interested study volunteers.

Why we are conducting the PREQUEL study?


The PREQUEL study is being conducted to:
• Investigate the safety and tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10 (CoQ) in pre-manifest participants who tested positive for the Huntington’s disease (HD) gene expansion.
• Determine whether high dosages of CoQ are well tolerated in people with the HD gene expansion who are pre-manifest. 
• Assess the usefulness of certain markers of HD in the blood, which may help measure the rate of disease progression or effects of medication. 
• Assess, by questionnaire, social relations, behavior and employment, in individuals who have tested positive for the HD gene and are pre-manifest. 
• Help us determine if it is possible to enroll healthy (“pre-manifest HD”) persons in a clinical trial as we plan for larger trials in the future.

 

What is pre-manifest Huntington disease?

 

Pre-manifest Huntington disease is defined as having been tested positive (CAGn expansion) for Huntington disease AND not having the features on your physical examination that would suggest a diagnosis of Huntington’s disease.

 

Should I participate if I do not want to know whether or not if I’m showing signs of manifest HD?


If you do NOT want to know whether or not you have motor features of HD you should NOT participate in this research study.

 

Who is eligible?

 

Main Inclusion Criteria

• Participants must be 18 years of age or older.
• Participants must have been previously tested gene positive for the CAGn expansion in the Huntingtin gene (>36 repeats) and be pre-manifest on physical examination.
• Concomitant medications are permitted with the exception of CoQ and Creatine > 5g/day.

 

Main 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.

 

How is privacy protected in the PREQUEL study?


The PREQUEL study is designed to respect and protect the confidentiality of the research participants.  Coded numbers will be assigned to each study participant in the collection of research data and a second coded number will be assigned for blood samples.  In addition participant’s records are protected under the federal Health Insurance Portability and Accountability Act (HIPAA) and to help us protect your privacy, we have applied for a Certificate of Confidentiality from the National Institutes of Health.

 

Are there risks involved?


Participants may experience mild heartburn, headache, feeling of tiredness and bowel symptoms. Participants may also experience distress due to uncertainties of not knowing when HD will start. There are no data available regarding the effect of CoQ in pregnant or nursing women. There is always the risk of previously unknown side effects occurring. 

During participation in the PREQUEL study blood samples will be collected.  The blood draws may cause mild discomfort and bruising at the site where the blood is taken, and sometimes cause people to feel lightheaded or faint during or shortly after having blood drawn.

Participants may experience feelings of frustration or anxiety while completing the testing of movement, mood, mental functioning, everyday functioning and thinking ability.  Participants are free to stop any test at any time for any reason.

 

What are the benefits of participating in the PREQUEL study?

Participants may or may not receive benefit from participation in this study.  A benefit of participation in the PREQUEL study is receiving additional evaluations by a study doctor who specializes in Huntington’s disease. 

Participants will contribute to the scientific knowledge about Huntington disease prior to the development of symptoms and about the safety and tolerability of CoQ in people with the Huntington disease gene.

 

Is there Literature on the PREQUEL study?

Related Documents:
PREQUEL Brochure May 2010
PREQUEL Press Release May 2009


Related Links:
ClinicalTrials.gov

 last updated: January 2011