UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000780
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sawada@unh.hosp.go.jp

Sponsor
Institute Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000937

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.