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: NA

Last verified: March 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 22, 2012
Last Updated Date	March 22, 2012
Start Date ^ICMJE	August 2008
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 22, 2012)	the incidence and severity of adverse events, vital signs, and laboratory parameters [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: Yes ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: March 22, 2012)	Change of IRLS sum score from the baseline to each visit [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Idiopathic Restless Legs Syndrome
Intervention ^ICMJE	Drug: SPM 962 Tansdermal patch Other Name: rotigotine
Study Arm (s)	Experimental: SPM 962 Rotigotine transdermal patch Intervention: Drug: SPM 962
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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	185
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject completed the preceding trial 243-07-003 (NCT00666965) Exclusion Criteria: Subject discontinued from the preceding trial 243-07-003 (NCT00666965) Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003 Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003. Subject had persistent hallucination or delusion during trial 243-07-003. Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline. Subject had orthostatic hypotension or a systolic blood pressure (SBP) ≤ 100 mmHg and had a decrease of SBP from spine to standing position ≥ 30 mmHg at baseline. Subject had a history of epilepsy, convulsion etc. during trial 243-07-003. Subject developed serious ECG abnormality at the baseline. Subject had QTc-interval ≥ 500 msec at the baseline or subject had an increase of QTc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had a QTc-interval > 470 msec in female or > 450 msec in male at the baseline. Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-003. Subject had a total bilirubin ≥ 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ≥ 100 IU/L) at the end of the period in trial 243-07-003. Subject had BUN ≥ 30 mg/dL or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-003. Subject who planned pregnancy during the trial. Subject was judged to be inappropriate for this trial by the investigator for the reasons other than above.
Gender	Both
Ages	20 Years to 79 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01562743
Other Study ID Numbers ^ICMJE	243-07-004
Has Data Monitoring Committee	No
Responsible Party	Otsuka Pharmaceutical Co., Ltd.
Study Sponsor ^ICMJE	Otsuka Pharmaceutical Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Pharmaceutical Co., Ltd.
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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