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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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One screening visit consisting of: neurological examination, interview on health topics, and questionnaires on health topics.

Reporting Groups
  Description
Ubiquinol

600mg ubiquinol daily for 24 weeks

Ubiquinol: Ubiquinol caplets 600mg/day

Placebo

Placebo daily for 24 weeks

Placebo: placebo


Participant Flow:   Overall Study
    Ubiquinol   Placebo
STARTED   6   5 
COMPLETED   6   4 
NOT COMPLETED   0   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ubiquinol

600mg ubiquinol daily for 24 weeks

Ubiquinol: Ubiquinol caplets 600mg/day

Placebo

Placebo daily for 24 weeks

Placebo: placebo

Total Total of all reporting groups

Baseline Measures
   Ubiquinol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   4   10 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      2  50.0%      2  20.0% 
Male      6 100.0%      2  50.0%      8  80.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   6   4   10 


  Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: clh2007@med.cornell.edu



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