Idiopathic Restless Legs Syndrome
Conditions
Interventions
investigational material(s)
Generic name etc : SPM962
INN of investigational material :
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for Inv
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Efficacy | — |
Outcome results
None listed