Unique ID issued by UMIN | UMIN000007521 |
---|---|
Receipt number | R000008852 |
Scientific Title | Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease |
Date of disclosure of the study information | 2012/03/17 |
Last modified on | 2015/05/15 23:35:26 |
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Japan |
Parkinson disease
Neurology |
Others
NO
We assumed that reduced CoQ10 showed the neuroprotective effects on patients with Parkinson disease (PD). We examine two groups; one group included subjects who have wearing off (A-group), and another group included subjects who have not been medicated with levodopa (B-group).
Safety,Efficacy
Confirmatory
UPDRS
A group : Change from baseline to 8th, 24th, 48th week, and post 8th week.
B group : Change from baseline to 8th, 24th, 48th, 72th, 96th week, and post 8th week.
1. Duration to protocol ended because of addition of levodopa or progression of disease.
2. A group : Change from baseline to 8th, 24th, 48th week, and post 8th week of time of daily on-time or off-time in their diary.
3. Progression of dyskinesia
4. Serum concentration of reduced CoQ10 of baseline, 8th, 24th, 48th week, and post 8th week.
Safety analysis
1) Adverse events except dyskinesia.
2) Screening laboratory studies included complete blood count, level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholesterol, HDL-cholesterol and triglyceride.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
YES
2
Treatment
Food |
Reduced CoQ10 capsule (55mg) 6 tablets 2 times a day (Kaneka)
A group for 48 weeks, B group for 96 weeks
Placebo capsule (6 tablets 2 times a day) is not included reduced CoQ10 (Kaneka).
A group for 48 weeks, B group for 96 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. Subjects had diagnosed PD according to the UK Brain Bank criteria.
2. A group : L-dopa/ DCI (over 300mg/day) and having wearing-off.
B group: without levodopa medication.
3. No change on medication for PD for eight weeks.
4. Modified Hohen-Yahr scale of on-phase between 0 to 3.
5. Outpatients are preferable than admitted patients.
6. The subjects are over 20 years-old of male or female.
7. Written informed consent must be obtained.
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.
80
1st name | |
Middle name | |
Last name | Asako Yoritaka |
Juntendo University School of Medicine, Juntendo Koshigaya Hospital
Neurology
Fukuroyama 560, Koshigayashi, Saitama, Japan
048-975-0321
1st name | |
Middle name | |
Last name | Asako Yoritaka |
Juntendo Koshigaya Hospital
Neurology
048-975-0321
Department of Neurology, Juntendo University School of Medicine
Grants-in-Aid for Scientific Reserch
Japan
KANEKA Coporation
NO
順天堂大学附属順天堂医院(東京都)、順天堂大学附属順天堂越谷病院(埼玉県)
2012 | Year | 03 | Month | 17 | Day |
Published
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.
Completed
2009 | Year | 02 | Month | 02 | Day |
2009 | Year | 03 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 17 | Day |
2015 | Year | 05 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008852