A Placebo-Controlled Study for SPM 962 in RLS Patients

Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2008
INTERVENTION: 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 Investigational material : Transdermal CONDITION: Idiopathic Restless Legs Syndrome PRIMARY OUTCOME: Safety and Efficacy 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
Epistemonikos ID: ac68c77db1330ddf8b7f1453e8682ded7564423a
First added on: Aug 26, 2024