Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03061513
• Date of registration: 13/02/2017
• Prospective Registration: No
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
• Scientific title: Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
• Date of first enrolment: February 28, 2012
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03061513
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Contacts

• Name: Claire Henchcliffe, MD DPhil
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Ubiquinol

Dietary Supplement: Placebo

Primary Outcome(s)

Number of Adverse Events [Time Frame: at 24 weeks]

Secondary Outcome(s)

Cerebral Redox Markers [Time Frame: at baseline and 8 weeks]

Secondary ID(s)

1112012060

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03061513