UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshihisa Takiyama
Organization	University of Yamanashi
Division name	Neurology
Address	Shimokato 1110, Chuo, Yamanashi, Japan
TEL	0552739896
Email	mmiwa@yamanashi.ac.jp

Public contact
Name of contact person	Yoshihisa Takiyama
Organization	University of Yamanashi
Division name	Neurology
Address	Shimokato 1110, Chuo, Yamanashi, Japan
TEL	055-273-9896
Homepage URL
Email	mmiwa@yamanashi.ac.jp

Sponsor
Institute	Department of Neurology, University of Yamanashi
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2013 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012136