臨床研究等提出・公開システム

Date of registration	July. 27, 2006
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220282

Scientific Title	A dose-finding study for SPM 962 in advanced Parkinson's disease patients with L-dopa adjunct therapy
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Otsuka Pharmaceutical Co., Ltd.
	Address	03-6361-7314
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	A multi-center, randomized, double-blind placebo-controlled two-arm study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1. Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHW-specified Intractable Neurodegenerative Diseases (1995)" 2. Aged over 30 years and less than 80 years at the time of informed consent 3. Hoehn & Yahr stage II - IV (on time) 4. Total UPDRS Part III score is over 10 at screening test (on time) 5. Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962 6. Subject has any of the following problematic symptoms 1) Wearing off phenomenon 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Not well controlled with L-dopa due to adverse effect 5) Weakening of L-dopa efficacy
	Exclusion Criteria
	Minimum Age	30age old over
	Maximum Age	79age old under
	Gender	Both
Health Condition or Problem Studied		Idiopathic Parkinson's disease
Intervention(s)		investigational material(s) Generic name etc : SPM 962 INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material : Transedarmal
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy, Safety
Secondary Outcome

Primary Sponsor	Otsuka Pharmaceutical Co., Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-060287
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 24, 2013	Detail	Changes
7	Dec. 24, 2013	Detail	Changes
6	June. 27, 2011	Detail	Changes
5	June. 27, 2011	Detail	Changes
4	May. 21, 2007	Detail	Changes
3	May. 21, 2007	Detail	Changes
2	July. 27, 2006	Detail	Changes
1	July. 27, 2006	Detail

List of change history