UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000780 |
|---|---|
| Receipt number | R000000937 |
| Scientific Title | A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease |
| Date of disclosure of the study information | 2007/08/01 |
| Last modified on | 2014/01/24 12:23:15 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease
Acronym
The usefulness of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease
Scientific Title
A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease
Scientific Title:Acronym
The usefulness of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make clear whether amantadine hydrochloride improves dyskinesias without worsening motor function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) UPDRS (parts 3 and 4) and Goetz score (measurements after amantadine hydrochloride and after placebo administration)
2) Incidence of adverse events
Key secondary outcomes
1) Correlation between blood concentrations of amantadine hydrochloride and the UPDRS (parts 3 and 4) and Goetz score changes
2) UPDRS (parts 3 and 4) and Goetz score changes stratified by the types of dyskinesias
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
An observation period (2 to 3 weeks)
An administration of amantadine hydrochloride (27 days)
A wash out period (15 days)
An administration of placebo (27 days)
Interventions/Control_2
An observation period (2 to 3 weeks)
An administration of placebo (27 days)
A wash out period (15 days)
An administration of amantadine hydrochloride (27 days)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients are 20 to 75 years-old, diagnosed as Parkinson disease (according to steps 1 and 2 of U.K. Parkinson's disease Society brain bank diagnostic criteria), and with dyskinesias of the limbs and the trunk
Key exclusion criteria
1) Patients prescribed with amantadine hydrochloride during the previous 2 weeks
2) Patients with psychiatric symptoms such as auditory hallucination or delusions
3) According to the following formula, creatinine clearance is less than 75mL/min/1.73m2
Male : (140-age)X weight(kg)/(72 X serum creatinine)(mg/dL)
Female : (140-age)X weight(kg)X 0.85/(72 X serum creatinine)(mg/dL)
4) Remarkable liver damage
5) Pregnant or possibly pregnant
6) History of epilepsy
7) Patients who are judged as inappropriate participants in the trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sawada |
Organization
Utano National Hospital, National Hospital Organization
Division name
Clinical Research Institute
Zip code
Address
8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
TEL
075-461-5121
sawaad@unh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Tsunamoto / Kaho Ishibashi |
Organization
Utano National Hospital, National Hospital Organization
Division name
Clinical Research Institute
Zip code
Address
8, Ondoyama, Narutaki, Ukyo-ku, Kyoto, Kyoto 616-8255, Japan
TEL
075-461-5121
Homepage URL
sawada@unh.hosp.go.jp
Sponsor or person
Institute
Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labors and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Musashi Hospital, National Center of Neurology and Psychiatry, Japan
Ehime University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.plosone.org/article/
Number of participants that the trial has enrolled
Results
RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5). UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD) of 1.83 (1.56)] compared with placebo-treated patients [0.03 (1.51)]. However, there were no significant effects on UPDRS-IVb or III scores.
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
| 2007 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 30 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000937
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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