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Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease

Not Applicable
Conditions
Parkinson disease
Registration Number
JPRN-UMIN000007521
Lead Sponsor
Department of Neurology, Juntendo University School of Medicine
Brief Summary

Methods:Rondomized, double-blind, placebo controlled, parallel-group pilot trials were conducted to assess the efficacy of ubiquinol-10 in Japanease patients with PD. Participants were divided two groups: PD experiencing wearing off (Group A), and early PD, without levodopa (Group B). Participants took 300mg of ubiquinol-10 or placebo per day for 48 weeks (GroupA) or 96 weeks (Group B). Results: In Group A, total Unified Parkinson's Disease Rating Scale (UPDRS) scores decreased in the ubuquinol-10 group (n=14; mean+-SD [-4.2+-8.2]), indicating improvement in symptoms. There was a statistically siginificant difference (p <0.05) compared with the placebo group (n= 12;2.9+--8.9). In Group B, UPDRS increased in the ubiquinol-10 group (n=14; 3.9+-8.0), as well as in the placebo group (n=8; 5.1+--10.3). Conclusions; Ubiquinol-10 may significantly improve PD with wearing off, as judged by total UPDRS scores, and that ubiqionol-10 is safe and well tolerated.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

1. The patietnt with parkinsonism due to corticobasal syndrome, multiple system atrophy, drug parkinsonism, hydrocephalus, essential tremor. 2. Modified Hohen-Yahr score of greater than 4. 3. The subjects had levodopa without DCI 4. The presence of other serious disease. 5. The presence of allergic response or side effects with drugs. 6. Subjects who are inappropriate for the study according to our judgment. 7. The subjects enrolled in other clinical trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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