PREQUEL - CoQ10 in Premanifest HD
The Huntington Study Group is studying the safety and tolerability of Coenzyme Q10 in people who are gene positive but who are not experiencing the symptoms that would lead to a clinical diagnosis.
CoQ10 is an antioxidant and a possible booster of cellular energy. Some HD mouse studies have shown benefit. A Phase III study of a smaller dosage a decade ago found a trend towards the slowing of disease progress that failed to reach statistical significance.
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.
Who is eligible?
Inclusion Criteria
• 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.
Link for more information:
The Huntington Study Group list of participating sites