A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: SPM 962
Intervention description: transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Intervention MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: SPM 962; rotigotine; Idiopathic Restless Legs Syndrome; RLS

Summary:

      The primary objective of this study is to investigate efficacy and safety of SPM 962 in
      Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group
      comparative study following once-daily multiple transdermal doses of SPM 962 within a range
      of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is 20 and more and less than 80 years of age and is able to think about
             her/his participation at the time of informed consent.

          2. Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical
             features according to the IRLSSG/NIH.

          3. The following subject will be included in the study

               -  Subject is not currently receiving treatment for RLS.

               -  Subject has previously received treatment of either L-dopa or dopamine agonists
                  and efficacy was observed in either of drugs.

          4. At baseline, subject has a score of ≧ 15 on the IRLS sum score and RLS symptoms occur
             twice and more a week (≧score 2 in IRLS Question 7)

          5. Subject has a score of ≧ 4 on the CGI Severity score at baseline

        Exclusion Criteria:

          1. Subject has secondary RLS in association with renal impairment such as uremia，iron
             deficiency anemia, and drug associated symptoms.

          2. Subject has, is suspected of having or has a history of sleep disorders such as sleep
             apnea syndrome, narcolepsy, sleep attacks/sudden onset of sleep.

          3. Subject has additional clinically relevant concomitant diseases or symptoms such as
             polyneuropathy (including diabetic neuropathy), akathisia，claudication
             varicoses，muscle fasciculation，painful legs moving toes and radiculopathy.

          4. Subject has other central nervous diseases like Parkinson's disease, dimentia,
             progressive supranuclear paresis, multisystem atrophy, Huntington's Chorea,
             amyotrophic lateral sclerosis, or Alzheimer's disease.

          5. At screening or baseline, subject has psychiatric condition like confusion,
             hallucination, delusion, excitation, deliria, abnormal behaviour.

          6. Subject has orthostatic hypotension or systolic BP marks ≦ 100 mm Hg and with a
             decrease of BP from supine to standing position of ≧ 30 mm Hg.

          7. Subject has a history of epilepsy, convulsion etc.

          8. Subject has serious cardiac dysfunction and/or arrhythmias (e.g., congestive heart
             failure Class III or IV by NYHA, myocardial infarction, angina pectoris, conduction
             system dysregulations, second or third degree AV block, complete left bundle branch
             block, sick-sinus-syndrome, ventricular fibrillation within twelve months prior to
             enrollment).

          9. Subject has arrhythmia and receiving Class Ia antiarrhythmic drugs(e.g., quinidine,
             procainamide), Class III antiarrhythmic drugs (e.g., amiodarone, sotalol)

         10. At screening and baseline, subject develops serious ECG abnormality. Subjects has
             QTc-interval >450 msec twice at screening. Subject has a the average QTc-interval from
             two ECGs >450 msec in males and >470 msec in females at baseline.

         11. Subject has long QT syndrome congenital.

         12. Subject has a serum potassium level < 3.5 mEq/L at screening.

         13. Subject has a total bilirubin ≧3.0 mg/dL or AST(GOT) and/or ALT(GPT) greater than 2.5
             times the upper limit of the reference range (or ≧100 IU/L) at screening.

         14. Subject has BUN ≧ 30 mg/dL or serum creatinine ≧2.0 mg/dl at screening.

         15. Subject has a history of allergic reaction to topical agents such as transdermal
             patch.

         16. Subject is pregnant or nursing or woman who plans pregnancy during the trial.

         17. Subject pursues shift work or is subject to other continuous non-disease-related life
             conditions which do not allow regular sleep at night.

         18. Subject has autoimmune disease, chronic active hepatitis or immune deficiency
             disorder.

         19. Subject has a malignant neoplastic disease requiring therapy within twelve months
             prior to screening.

        19. Subject received an investigational drug from other clinical trial within the last 12
        months prior to baseline.

        20. Subject is judged to be inappropriate for this trial by investigator on the other than
        above.