Trial Outcomes & Findings for Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers (NCT NCT03061513)
NCT ID: NCT03061513
Last Updated: 2017-05-23
Results Overview
The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.
COMPLETED
PHASE2
11 participants
at 24 weeks
2017-05-23
Participant Flow
Recruited from the clinical practice at Weill Cornell Medicine's (WCM) Parkinson's Disease Department as well as Weill Cornell Medicine, and utilized flyers.
One screening visit consisting of: neurological examination, interview on health topics, and questionnaires on health topics.
Participant milestones
| Measure |
Ubiquinol
600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day
|
Placebo
Placebo daily for 24 weeks
Placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
Baseline characteristics by cohort
| Measure |
Ubiquinol
n=6 Participants
600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day
|
Placebo
n=4 Participants
Placebo daily for 24 weeks
Placebo: placebo
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 weeksPopulation: ITT
The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.
Outcome measures
| Measure |
Ubiquinol
n=6 Participants
600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day
|
Placebo
n=5 Participants
Placebo daily for 24 weeks
Placebo: placebo
|
|---|---|---|
|
Number of Adverse Events
|
27 Number of Adverse Events
|
12 Number of Adverse Events
|
SECONDARY outcome
Timeframe: at baseline and 8 weeksChange from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy
Outcome measures
| Measure |
Ubiquinol
n=6 Participants
600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day
|
Placebo
n=4 Participants
Placebo daily for 24 weeks
Placebo: placebo
|
|---|---|---|
|
Cerebral Redox Markers
|
-11.98 Ratio
Standard Deviation 18.57
|
6.23 Ratio
Standard Deviation 23.19
|
Adverse Events
Ubiquinol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ubiquinol
n=6 participants at risk
600mg ubiquinol daily for 24 weeks
Ubiquinol: Ubiquinol caplets 600mg/day
|
Placebo
n=5 participants at risk
Placebo daily for 24 weeks
Placebo: placebo
|
|---|---|---|
|
General disorders
Fever
|
0.00%
0/6
|
20.0%
1/5
|
|
General disorders
Motor Vehicle Accident
|
0.00%
0/6
|
20.0%
1/5
|
|
Infections and infestations
Common Cold Syndrome
|
50.0%
3/6
|
40.0%
2/5
|
|
General disorders
Dizziness
|
66.7%
4/6
|
0.00%
0/5
|
|
General disorders
Sleepiness
|
66.7%
4/6
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
Skin rash, itching
|
16.7%
1/6
|
20.0%
1/5
|
|
General disorders
Nausea
|
33.3%
2/6
|
0.00%
0/5
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6
|
40.0%
2/5
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/6
|
20.0%
1/5
|
|
Nervous system disorders
Cognitive decline
|
33.3%
2/6
|
0.00%
0/5
|
|
Psychiatric disorders
Depression
|
33.3%
2/6
|
0.00%
0/5
|
|
General disorders
Moodiness
|
16.7%
1/6
|
0.00%
0/5
|
|
General disorders
Stomatitis
|
0.00%
0/6
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
83.3%
5/6
|
20.0%
1/5
|
|
General disorders
Sudden falls
|
16.7%
1/6
|
0.00%
0/5
|
|
Vascular disorders
Peripheral edema
|
0.00%
0/6
|
20.0%
1/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place