UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010371 |
|---|---|
| Receipt number | R000012136 |
| Scientific Title | Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2016/05/12 13:51:19 |
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Basic information
Public title
Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease.
Acronym
Study of zonisamide to tremor in patients with early Parkinson's disease.
Scientific Title
Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease.
Scientific Title:Acronym
Study of zonisamide to tremor in patients with early 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 evaluate efficacy and safety of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. We use Actigraph and Unified Parkinson's Disease Rating Scale (UPDRS) to evaluate it.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of tremor detected by actigraph
Key secondary outcomes
The change of UPDRS Part 2,3
The change of RBDSQ-J
Adverse Events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Start 25mg of Zonisamide and carry out observation 24weeks.
Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as Parkinson's disease and meet the following criteria
1) Patients who take only L-dopa/DCI 200mg/Day or less ( Duration of internal use does not matter)
2) Patients who haven't take zonisamide before.
3) Patients who give consents
Key exclusion criteria
1) Patients with Parkinsonism other than Parkinson's disease
2) Patients who have taken zonisamide
3) Patients with dementia : [Mini Mental State Examination (MMSE) score is less than 22points
4) Patients with severs disease of heart, renal, liver, and other life-threatening diseases
5) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Takiyama |
Organization
University of Yamanashi
Division name
Neurology
Zip code
Address
Shimokato 1110, Chuo, Yamanashi, Japan
TEL
0552739896
mmiwa@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Takiyama |
Organization
University of Yamanashi
Division name
Neurology
Zip code
Address
Shimokato 1110, Chuo, Yamanashi, Japan
TEL
055-273-9896
Homepage URL
mmiwa@yamanashi.ac.jp
Sponsor or person
Institute
Department of Neurology, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, University of Yamanashi
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
| 2013 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 08 | 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 | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012136
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
