Coenzyme Q10 in Huntington's Disease (HD)
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: coenzyme Q10; placebo
Intervention description: 4 - 300 mg CoQ chewable wafers taken orally twice a day; an inactive substance
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 609.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Huntington's disease; Huntington disease; HD; coenzyme Q10; CoQ

Summary:

      The goals of this trial are to determine if coenzyme Q10 is effective in slowing the
      worsening symptoms of Huntington's disease and to learn about the safety and acceptability of
      long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for enrollment into this study, subjects must meet the following eligibility
        criteria within 28 days prior to randomization:

          -  Subjects must have clinical features of HD and a confirmed family history of HD, OR a
             CAG repeat expansion ≥ 36.

          -  TFC > 9.

          -  Must be ambulatory and not require skilled nursing care.

          -  Age ≥ 16 years.

          -  Women must not be able to become pregnant (e.g., post menopausal, surgically sterile
             or using adequate birth control methods for the duration of the study).

          -  If psychotropic medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines,
             antidepressants), they must be at a stable dosage for four weeks prior to
             randomization and should be maintained at a constant dosage throughout the study, as
             possible. (Note: stable dosing of tetrabenazine is allowable.) Any changes to these
             medications mandated by clinical conditions will be systematically recorded and the
             subject will be permitted to remain in the trial.

          -  Able to give informed consent and comply with trial procedures

          -  Able to take oral medication.

          -  May be required to identify an informant or caregiver who will be willing and able to
             supervise the daily dosing of study medications and to maintain control of study
             medications in the home.

          -  A designated individual will be identified by the subject to participate in the
             ongoing consent process should the subject's cognitive capacity to consent become
             compromised during participation in the study.

        Exclusion Criteria:

          -  History or known sensitivity of intolerability to CoQ.

          -  Exposure to any investigational drug within 30 days of the Baseline visit.

          -  Clinical evidence of unstable medical illness in the investigator's judgment.

          -  Unstable psychiatric illness defined as psychosis (hallucinations or delusions),
             untreated major depression or suicidal ideation within 90 days of the Baseline visit.

          -  Substance (alcohol or drug) abuse within one year of the Baseline visit.

          -  Women who are pregnant or breastfeeding.

          -  Use of supplemental coenzyme Q10 within 30 days prior to the Baseline visit

          -  Clinically serious abnormalities in the screening laboratory studies (Screening
             creatinine greater than 2.0, alanine aminotransferase (ALT) or total bilirubin greater
             than 3 times the upper limit of normal, absolute neutrophil count of ≤1000/ul,
             platelet concentration of <100,000/ul, hematocrit level of <33 for female or <35 for
             male, or coagulation tests > 1.5 time upper limit of normal).

          -  Known allergy to FD&C yellow #5 or any other ingredient in the study drug (active and
             placebo)