A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: SPM 962
Intervention description: Tansdermal patch
Intervention MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.