Phase 2
Completed N=11
Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
Source: ClinicalTrials.gov NCT03061513 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Number of Adverse Events — 27; 12 Number of Adverse Events
Summary
The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic resonance spectroscopy (MRS) and blood test for biological markers taken during the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
27; 12 | — |
| SECONDARY Cerebral Redox Markers |
-11.98; 6.23 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of PD according to the Untied Kingdom (UK) Brain Bank Criteria, and confirmed by a Movement Disorders neurologist;
- age 40-75 years; diagnosis within 5 years of study participation;
- PD medications able to remain at stable doses in the opinion of the enrolling investigator;
- able to undergo MRI;
- absence of significant medical, psychiatric, and other neurological disease;
- absence of dementia and Mini-Mental State Examination (MMSE) > 26.
Exclusion Criteria
- failure to meet diagnosis by above criteria;
- time since diagnosis > 5 years before study participation;
- PD medications not predicted to remain at stable doses in the opinion of the enrolling investigator;
- unable to undergo MRI;
- unable to comply with informed consent process;
- presence of significant medical, psychiatric (including major depressive disorder) or other neurological (including epilepsy, brain tumor, stroke) disease;
- diagnosis of dementia and/or MMSE 26 or lower;
- possibility of pregnancy (negative test required in women of childbearing age);
- taking medications including antipsychotic agents and dopamine- blocking anti-emetic agents;
- taking Coenzyme Q10;
- participation in another clinical trial within the last 3 months.
Data sourced from ClinicalTrials.gov (NCT03061513). 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.