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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Tracking Information | |||
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First Submitted Date ICMJE | March 22, 2012 | ||
First Posted Date ICMJE | March 26, 2012 | ||
Results First Submitted Date ICMJE | February 3, 2014 | ||
Results First Posted Date ICMJE | April 23, 2014 | ||
Last Update Posted Date | April 23, 2014 | ||
Study Start Date ICMJE | August 2008 | ||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
the incidence and severity of adverse events, vital signs, and laboratory parameters [ Time Frame: Up to 53 weeks ] The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters.
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Change of IRLS sum score from the baseline to each visit [ Time Frame: Up to 53 weeks ] | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome | ||
Official Title ICMJE | An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome | ||
Brief Summary | The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Idiopathic Restless Legs Syndrome | ||
Intervention ICMJE | Drug: SPM 962
Tansdermal patch
Other Name: rotigotine
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Study Arms ICMJE | Experimental: SPM 962
Rotigotine transdermal patch
Intervention: Drug: SPM 962
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Publications * | Inoue Y, Hirata K, Hayashida K, Hattori N, Tomida T, Garcia-Borreguero D; Rotigotine Study Group. Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Jan 10;40:326-33. doi: 10.1016/j.pnpbp.2012.10.012. Epub 2012 Oct 25. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
185 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | October 2010 | ||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 79 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01562743 | ||
Other Study ID Numbers ICMJE | 243-07-004 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Otsuka Pharmaceutical Co., Ltd. | ||
Study Sponsor ICMJE | Otsuka Pharmaceutical Co., Ltd. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Otsuka Pharmaceutical Co., Ltd. | ||
Verification Date | March 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |