UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010596
Receipt number R000012290
Scientific Title Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo
Date of disclosure of the study information 2013/05/01
Last modified on 2015/10/25 10:05:01

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Basic information

Public title

Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo

Acronym

MAP-J

Scientific Title

Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo

Scientific Title:Acronym

MAP-J

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For Parkinson's disease with motor fluctuations, compared the efficacy and safety of memantine and amantadine.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Improvement of dyskinesias

Key secondary outcomes

Changes in cognitive function score
Changes in REM sleep behavior disorder


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Memantine preceding arm
Titrate the memantine, administered for 3 months. And tapering memantine and amantadine titrate the dose for 3 months.

Interventions/Control_2

Amantadine preceding arm
Titrate the amantadine, administered for 3 months. And tapering amantadine and memantine titrate the dose for 3 months.

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

Key inclusion criteria

1)dyskinesia with wearing off
2)Cognitive dysfunction(Moca-J point less than 26)

Key exclusion criteria

1)Patient has been administered amantadine or memantine already.
2)Patient dose needs to be changed during the study period cholinesterase inhibitors.
3)Patients scheduled to come into effect during the study period deep brain stimulation surgery(DBS).
4)Women and lactating women might be pregnant, are pregnant.
5)In addition, patients attending physician was deemed inappropriate.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobutaka Hattori

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code


Address

2-1-1 Hongo Bunkyo Tokyo 113-8421 Japan

TEL

03-3813-3111

Email

nhattori@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taku Hatano

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code


Address

2-1-1 Hongo Bunkyo Tokyo 113-8421 Japan

TEL

03-3813-3111

Homepage URL


Email

thatano@juntendo.ac.jp


Sponsor or person

Institute

Department of Neurology, Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

2013 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Terminated

Date of protocol fixation

2013 Year 03 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 25 Day

Last modified on

2015 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012290


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name