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A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01628848
First received: June 24, 2012
Last updated: February 3, 2014
Last verified: February 2014
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: SPM 962
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SPM 962 SPM 962 transdermal patch
Placebo Placebo transdermal patch

Participant Flow:   Overall Study
    SPM 962   Placebo
STARTED   87   87 
COMPLETED   75   73 
NOT COMPLETED   12   14 
Adverse Event                9                7 
Lack of Efficacy                0                4 
Withdrawal by Subject                0                2 
Physician Decision                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Excluded 1 sebject of each arm by vaiolation of protocol

Reporting Groups
  Description
SPM 962 SPM 962 transdermal patch
Placebo Placebo transdermal patch
Total Total of all reporting groups

Baseline Measures
   SPM 962   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   86   172 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   24   26   50 
>=65 years   62   60   122 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.0  (6.8)   66.8  (8.3)   66.9  (7.5) 
Gender 
[Units: Participants]
     
Female   52   42   94 
Male   34   44   78 
Region of Enrollment 
[Units: Participants]
     
Japan   87   87   174 


  Outcome Measures
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1.  Primary:   Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score   [ Time Frame: baseline, 12 weeks after dosing ]

2.  Secondary:   UPDRS Part 2 Sum Score (Average Score of on State and Off State)   [ Time Frame: baseline, 12 weeks after dosing ]

3.  Secondary:   Off Time   [ Time Frame: baseline, 12 weeks after dosing ]

4.  Secondary:   Effective Rate in UPDRS Part 3 Sum Score   [ Time Frame: Baseline, 12 weeks after dosing ]

5.  Secondary:   UPDRS Part 1 Sum Score   [ Time Frame: Baseline, 12 weeks after dosing ]

6.  Secondary:   Effective Rate in Off Time   [ Time Frame: Baseline, 12 weeks after dosing. ]

7.  Secondary:   UPDRS Part 2 Sum Score (on State)   [ Time Frame: Baseline, 12 weeks after dosing ]

8.  Secondary:   UPDRS Part 2 Sum Score (Off State)   [ Time Frame: Baseline, 12 weeks after dosing ]

9.  Secondary:   UPDRS Part 4 Sum Score   [ Time Frame: Baseline, 12 weeks after dosing ]

10.  Secondary:   Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score   [ Time Frame: Baseline, 12 weeks after dosing ]

11.  Secondary:   Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.   [ Time Frame: Baseline, 12 weeks after dosing ]

12.  Secondary:   The Modified Hoehn & Yahr Severity of Illness   [ Time Frame: Baseline, 12 weeks after dosing ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
phone: +81-3-6131-7366



Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01628848     History of Changes
Other Study ID Numbers: 243-05-001
JapicCTI-060287 ( Other Identifier: JAPIC )
Study First Received: June 24, 2012
Results First Received: February 3, 2014
Last Updated: February 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare