Phase 2
Completed N=91
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
Source: ClinicalTrials.gov NCT00920699 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment. — 90.0; 93.1; 81.3 percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment. |
90.0; 93.1; 81.3 | — |
| SECONDARY 8OHdG Levels |
0.15; -1.56; 0.55 | — |
| SECONDARY CoQ10 Levels |
1.82; 1.92; 2.33 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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.
- Subjects with known allergy to FD&C #6 yellow food coloring.
Data sourced from ClinicalTrials.gov (NCT00920699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.