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A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537485
First Posted: October 1, 2007
Last Update Posted: March 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
Results First Submitted: February 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Early 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
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Reporting Groups
  Description
SPM962 transdermal application of SPM962, 1 time per day
Placebo transdermal application of placebo, 1 time per day

Participant Flow:   Overall Study
    SPM962   Placebo
STARTED   90   90 
COMPLETED   75   80 
NOT COMPLETED   15   10 
Adverse Event                10                5 
Withdrawal by Subject                3                2 
Withdrawal by Subject                1                3 
Physician Decision                1                0 



  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 3 subjects (SPM962:2, placebo:1) because lack of assessment of efficacy, and 1 (plasebo) for not matching with the inclusion criteria.

Reporting Groups
  Description
SPM962 transdermal application of SPM962, 1 time per day
Placebo transdermal application of placebo, 1 time per day
Total Total of all reporting groups

Baseline Measures
   SPM962   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 88   88   176 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   36   35   71 
>=65 years   52   53   105 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.1  (8.1)   66.2  (7.9)   65.6  (8.0) 
Gender 
[Units: Participants]
     
Female   55   51   106 
Male   33   37   70 
Region of Enrollment 
[Units: Participants]
     
Japan   88   88   176 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3   [ Time Frame: baseline, end of maintenance period ]

2.  Secondary:   Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3   [ Time Frame: baseline, end of maintenance period ]

3.  Secondary:   Mean Change in UPDRS Part 2 Sum Score   [ Time Frame: Baseline, every two weeks ]

4.  Secondary:   Efficacy Rate in UPDRS Part 2 Sum Score   [ Time Frame: Baseline, every two weeks ]

5.  Secondary:   UPDRS Part 3 Sum Score   [ Time Frame: Baseline, every two weeks ]

6.  Secondary:   Efficacy Rate in UPDRS Part 3 Sum Score   [ Time Frame: Baseline, every two weeks ]

7.  Secondary:   UPDRS Part 1 Sum Score   [ Time Frame: Baseline, every two weeks ]

8.  Secondary:   UPDRS Part 4 Sum Score   [ Time Frame: Baseline, every two weeks ]

9.  Secondary:   Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4   [ Time Frame: Baseline, every two weeks ]

10.  Secondary:   The Modified Hoehn and Yahr Stage   [ Time Frame: Baseline, end of maintenance period ]


  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: NCT00537485     History of Changes
Other Study ID Numbers: 243-07-001
First Submitted: September 27, 2007
First Posted: October 1, 2007
Results First Submitted: February 3, 2014
Results First Posted: March 19, 2014
Last Update Posted: March 19, 2014