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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007521
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Neurology, Juntendo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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