A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients

Inclusion criteria

• 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.
• Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical features according to the IRLSSG/NIH.
• 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.
• 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)
• Subject has a score of ≧ 4 on the CGI Severity score at baseline

Exclusion criteria

• Subject has secondary RLS in association with renal impairment such as uremia，iron deficiency anemia, and drug associated symptoms.
• 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.
• 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.
• 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.
• At screening or baseline, subject has psychiatric condition like confusion, hallucination, delusion, excitation, deliria, abnormal behaviour.
• 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.
• Subject has a history of epilepsy, convulsion etc.
• 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).
• Subject has arrhythmia and receiving Class Ia antiarrhythmic drugs(e.g., quinidine, procainamide), Class III antiarrhythmic drugs (e.g., amiodarone, sotalol)
• 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.
• Subject has long QT syndrome congenital.
• Subject has a serum potassium level < 3.5 mEq/L at screening.
• 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.
• Subject has BUN ≧ 30 mg/dL or serum creatinine ≧2.0 mg/dl at screening.
• Subject has a history of allergic reaction to topical agents such as transdermal patch.
• Subject is pregnant or nursing or woman who plans pregnancy during the trial.
• Subject pursues shift work or is subject to other continuous non-disease-related life conditions which do not allow regular sleep at night.
• Subject has autoimmune disease, chronic active hepatitis or immune deficiency disorder.
• Subject has a malignant neoplastic disease requiring therapy within twelve months prior to screening.

• Subject received an investigational drug from other clinical trial within the last 12 months prior to baseline.

• Subject is judged to be inappropriate for this trial by investigator on the other than above.