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

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ClinicalTrials.gov Identifier: NCT03061513
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Drug: Ubiquinol
Dietary Supplement: Placebo
Enrollment 11
Recruitment Details Recruited from the clinical practice at Weill Cornell Medicine’s (WCM) Parkinson’s Disease Department as well as Weill Cornell Medicine, and utilized flyers.
Pre-assignment Details One screening visit consisting of: neurological examination, interview on health topics, and questionnaires on health topics.
Arm/Group Title Ubiquinol Placebo
Hide Arm/Group Description

600mg ubiquinol daily for 24 weeks

Ubiquinol: Ubiquinol caplets 600mg/day

Placebo daily for 24 weeks

Placebo: placebo

Period Title: Overall Study
Started 6 5
Completed 6 4
Not Completed 0 1
Arm/Group Title Ubiquinol Placebo Total
Hide Arm/Group Description

600mg ubiquinol daily for 24 weeks

Ubiquinol: Ubiquinol caplets 600mg/day

Placebo daily for 24 weeks

Placebo: placebo

Total of all reporting groups
Overall Number of Baseline Participants 6 4 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  50.0%
0
   0.0%
3
  30.0%
>=65 years
3
  50.0%
4
 100.0%
7
  70.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Female
0
   0.0%
2
  50.0%
2
  20.0%
Male
6
 100.0%
2
  50.0%
8
  80.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 4 participants 10 participants
6
 100.0%
4
 100.0%
10
 100.0%
1.Primary Outcome
Title Number of Adverse Events
Hide Description The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.
Time Frame at 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Ubiquinol Placebo
Hide Arm/Group Description:

600mg ubiquinol daily for 24 weeks

Ubiquinol: Ubiquinol caplets 600mg/day

Placebo daily for 24 weeks

Placebo: placebo

Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: Number of Adverse Events
27 12
2.Secondary Outcome
Title Cerebral Redox Markers
Hide Description Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy
Time Frame at baseline and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ubiquinol Placebo
Hide Arm/Group Description:

600mg ubiquinol daily for 24 weeks

Ubiquinol: Ubiquinol caplets 600mg/day

Placebo daily for 24 weeks

Placebo: placebo

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: Ratio
-11.98  (18.57) 6.23  (23.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ubiquinol Placebo
Hide Arm/Group Description

600mg ubiquinol daily for 24 weeks

Ubiquinol: Ubiquinol caplets 600mg/day

Placebo daily for 24 weeks

Placebo: placebo

All-Cause Mortality
Ubiquinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ubiquinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ubiquinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   3/5 (60.00%) 
Gastrointestinal disorders     
Constipation   2/6 (33.33%)  2/5 (40.00%) 
Upset stomach   0/6 (0.00%)  1/5 (20.00%) 
General disorders     
Fever *  0/6 (0.00%)  1/5 (20.00%) 
Motor Vehicle Accident *  0/6 (0.00%)  1/5 (20.00%) 
Dizziness   4/6 (66.67%)  0/5 (0.00%) 
Sleepiness   4/6 (66.67%)  1/5 (20.00%) 
Nausea   2/6 (33.33%)  0/5 (0.00%) 
Moodiness   1/6 (16.67%)  0/5 (0.00%) 
Stomatitis   0/6 (0.00%)  1/5 (20.00%) 
Sudden falls   1/6 (16.67%)  0/5 (0.00%) 
Infections and infestations     
Common Cold Syndrome   3/6 (50.00%)  2/5 (40.00%) 
Musculoskeletal and connective tissue disorders     
Lumbar pain   5/6 (83.33%)  1/5 (20.00%) 
Nervous system disorders     
Cognitive decline   2/6 (33.33%)  0/5 (0.00%) 
Psychiatric disorders     
Depression   2/6 (33.33%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin rash, itching   1/6 (16.67%)  1/5 (20.00%) 
Vascular disorders     
Peripheral edema   0/6 (0.00%)  1/5 (20.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Claire Henchcliffe
Organization: Weill Cornell Medical College
Phone: 2127462584
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03061513     History of Changes
Other Study ID Numbers: 1112012060
First Submitted: February 13, 2017
First Posted: February 23, 2017
Results First Submitted: February 22, 2017
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017