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

NCT03061513 | Completed Phase 2 Results

• 1 other identifier: 1112012060
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; ubiquinol; CoQ10; magnetic resonance spectroscopy; lactate; glutathione

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.

  at 24 weeks

Secondary Outcomes (1)

• Cerebral Redox Markers

  at baseline and 8 weeks

Study Arms (2)

Ubiquinol

ACTIVE COMPARATOR

600mg ubiquinol daily for 24 weeks

Drug: Ubiquinol

Placebo

PLACEBO COMPARATOR

Placebo daily for 24 weeks

Dietary Supplement: Placebo

Interventions

Ubiquinol DRUG

Ubiquinol caplets 600mg/day

Ubiquinol

Placebo DIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

ubiquinol

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Claire Henchcliffe
• Organization: Weill Cornell Medical College

clh2007@med.cornell.edu

2127462584

Study Officials

• Claire Henchcliffe, MD DPhil

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: February 28, 2012
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share