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

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.
ClinicalTrials.gov Identifier: NCT01562743
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Idiopathic Restless Legs Syndrome
Intervention: Drug: SPM 962

  Participant Flow

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
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 
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

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.
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Reporting Groups
SPM 962 Rotigotine transdermal patch

Baseline Measures
   SPM 962 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   157 
>=65 years   28 
[Units: Years]
Mean (Standard Deviation)
 49.8  (13.1) 
[Units: Participants]
Female   113 
Male   72 
Region of Enrollment 
[Units: Participants]
Japan   185 

  Outcome Measures

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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01562743     History of Changes
Other Study ID Numbers: 243-07-004
First Submitted: March 22, 2012
First Posted: March 26, 2012
Results First Submitted: February 3, 2014
Results First Posted: April 23, 2014
Last Update Posted: April 23, 2014