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A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01562743
First received: March 22, 2012
Last updated: March 26, 2014
Last verified: March 2014
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Idiopathic Restless Legs Syndrome
Intervention: Drug: SPM 962

  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

Rotigotine transdermal patch

A patch containing 2.25 - 6.75mg of rotigotine was administered once a day.


Participant Flow:   Overall Study
    SPM 962  
STARTED     185  
COMPLETED     133  
NOT COMPLETED     52  
Adverse Event                 29  
Lack of Efficacy                 3  
Withdrawal by Subject                 13  
Protocol Violation                 1  
Discontinuation criteria                 2  
Lost to Follow-up                 2  
Physician Decision                 2  



  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.
No text entered.

Reporting Groups
  Description
SPM 962 Rotigotine transdermal patch

Baseline Measures
    SPM 962  
Number of Participants  
[units: participants]
  185  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     157  
>=65 years     28  
Age  
[units: years]
Mean ± Standard Deviation
  49.8  ± 13.1  
Gender  
[units: participants]
 
Female     113  
Male     72  
Region of Enrollment  
[units: participants]
 
Japan     185  



  Outcome Measures
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1.  Primary:   The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters   [ Time Frame: Up to 54 weeks ]

2.  Primary:   Augmentation   [ Time Frame: Up to 53 weeks ]

3.  Primary:   Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit   [ Time Frame: Baseline, Up to 53 weeks ]

4.  Secondary:   Change of IRLS Sum Score From the Baseline to Each Visit   [ Time Frame: Baseline, Up to 53 weeks ]

5.  Secondary:   Efficacy Rate in IRLS Sum Score   [ Time Frame: Baseline, Up to 53 weeks ]

6.  Secondary:   Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit   [ Time Frame: Baseline, Up to 52 weeks ]

7.  Secondary:   Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit   [ Time Frame: Baseline, Up to 53 weeks ]


  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: +81-6361-7366


No publications provided by Otsuka Pharmaceutical Co., Ltd.

Publications automatically indexed to this study:

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01562743     History of Changes
Other Study ID Numbers: 243-07-004
Study First Received: March 22, 2012
Results First Received: February 3, 2014
Last Updated: March 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare