Idiopathic Restless Legs Syndrome
Conditions
Interventions
investigational material(s)
Generic name etc : SPM962 4.5
INN of investigational material :
Therapeutic category code : 116 Antiperkinsonism agents
Dosage and Administration for Investigational mater
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients whose condition has been diagnosed as RLS by meeting all 4 of the IRLSSG/NIH criteria 2. Patients who meet any of the following criteria relating to RLS treatment: - Patients who have never received treatment for RLS - Patients who have received treatment for RLS in the past and responded to L-dopa or dopamine agonists (Response to other RLS medicines is irrelevant.) 3. Patients who have an IRLS total score of >= 15 at baseline 4. Patients who experience symptoms in the evening or during the night on at least two days a week within 14 days prior to commencement of study treatment 5. Patients and their partners can practice contraception at the end of follow-up observation period or by 1 week after the end of treatment
Exclusion criteria
Exclusion criteria: 1. Patients who have previously participated in a clinical trial of SPM962 and taken the investigational product (IP) 2. Patients with secondary RLS induced by renal impairment (uremia), iron deficiency anemia, drugs, pregnancy, etc 3. Patients who currently suffer, are at risk of developing, or have a history of sleep disorder such as sleep apnea syndrome, narcolepsy, and sleep attacks/sudden onset of sleep 4. Patients who have concomitant diseases or symptoms which may affect the symptoms of RLS, such as polyneuropathy (including diabetic neuropathy), akathisia, claudication, varicoses, muscle fasciculation, painful legs and moving toes syndrome, radiculopathy and folate deficiency 5. Patients who have other CNS diseases such as Parkinson's disease, dementia, progressive supranuclear paresis, multisystem atrophy, Huntington's Chorea, amyotrophic lateral sclerosis, and Alzheimer's disease 6. Patients who have psychiatric conditions such as confusion, hallucination, delusion, and excitation, or patients who have abnormal behavior such as delirium, obsessive compulsive disorder, and impulse control disorder at the time of the screening test or baseline examination 7. Patients whose SBP declines by at least 30 mmHg from supine to standing position based on the orthostatic hypotension assessment, or patients who develop orthostatic hypotension at baseline 8. Patients who have a history of epilepsy, convulsion, etc 9. Patients who have complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the NYHA classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris) 10. Patients with arrhythmia who have been taking Class 1a antiarrhythmic drugs (eg, quinidine, procainamide) or Class 3 antiarrhythmic drugs (eg, amiodarone, sotalol) 11. Patients who have a serious ECG abnormality at the screening test and at the baseline examination Patients who show QTc intervals exceeding 450 ms in both ECGs in the screening test Patients who have an average QTc interval from the two ECGs in the baseline assessment that exceeds 470 ms (for females) or 450 ms (for males) 12. Patients with congenital long QT syndrome 13. Patients whose serum potassium level is = 3.0mg/dL, or whose AST(GOT) and ALT(GPT) are equal or more than 2.5 times the reference range of the clinical site (or >= 100IU/L) at the screening test 15. Patients whose BUN level is >= 30mg/dL, or whose serum creatinine level is >= 2.0mg/dL at the screening test 16. Patients who have a history of allergy to topical agents such as transdermal patch 17. Patients who are pregnant or nursing or who wish to become pregnant during the study period 18. Patients who habitually drink alcohol or smoke excessively 19. Patients who engage in evening shift work or other such shift work, or whose work or circumstances makes it difficult to maintain a regular period of sleep 20. Patients who engage in hazardous work such as driving a vehicle, operating machinery, or working in a high location. 21. Patients with autoimmune disease, chronic active hepatitis, or immune deficiency disorder 22. Patients who have a complication or history of malignant neoplastic disease, or received treatmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IRLS total score Change from the baseline to the end of dose-titration/dose-maintenance period week 0, 1,3, 5, 7, 9, 11, 13 (or discontinuation) | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI improvement PGI improvement week 0, 3, 5, 7, 13 (or discontinuation) PSQI week 0, 7, 13 (or discontinuation) Each item of IRLS week 0, 1, 3, 5, 7, 9, 11, 13 (or discontinuation) | — |
Outcome results
None listed