A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)
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ClinicalTrials.gov Identifier: NCT01562743 |
Recruitment Status :
Completed
First Posted : March 26, 2012
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
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Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Idiopathic Restless Legs Syndrome |
Intervention |
Drug: SPM 962 |
Enrollment | 185 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | SPM 962 |
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Rotigotine transdermal patch A patch containing 2.25 - 6.75mg of rotigotine was administered once a day. |
Period Title: Overall Study | |
Started | 185 |
Completed | 133 |
Not Completed | 52 |
Reason Not Completed | |
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
Arm/Group Title | SPM 962 | |
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Rotigotine transdermal patch | |
Overall Number of Baseline Participants | 185 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 185 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
157 84.9%
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>=65 years |
28 15.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 185 participants | |
49.8 (13.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 185 participants | |
Female |
113 61.1%
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Male |
72 38.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Japan | Number Analyzed | 185 participants |
185 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
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 |