UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Acronym
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Scientific Title
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Scientific Title:Acronym
Randomized, Double-blind, Placebo-controlled trial on Reduced Coenzyme Q10 in Parkinson Disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Reduced CoQ10 capsule (55mg) 6 tablets 2 times a day (Kaneka)
A group for 48 weeks, B group for 96 weeks
Interventions/Control_2
Placebo capsule (6 tablets 2 times a day) is not included reduced CoQ10 (Kaneka).
A group for 48 weeks, B group for 96 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key 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.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asako Yoritaka |
Organization
Juntendo University School of Medicine, Juntendo Koshigaya Hospital
Division name
Neurology
Zip code
Address
Fukuroyama 560, Koshigayashi, Saitama, Japan
TEL
048-975-0321
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asako Yoritaka |
Organization
Juntendo Koshigaya Hospital
Division name
Neurology
Zip code
Address
TEL
048-975-0321
Homepage URL
Sponsor or person
Institute
Department of Neurology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Reserch
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KANEKA Coporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 17 | Day |
Last modified on
| 2015 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008852
