NCT01084551已完成3 期
A Phase 3 Multi-Center, Placebo-Controlled, Double Blind, 3-Armed Parallel Group, Comparative Study of SPM 962 4.5 and 6.75 mg/Day to Investigate Superiority to Placebo in Patients With Restless Legs Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 284
- 主要终点
- International Restless Legs Syndrome Rating Scale (IRLS) Total Score
研究概览
简要总结
The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed parallel group comparison study.
Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale (IRLS) total score from baseline to the end of the dose-maintenance period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose condition has been diagnosed as RLS by meeting all 4 of the International Restless legs Syndrome Study Group/ National Institute of Health (IRLSSG/NIH) criteria
- •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.)
- •Patients who have an IRLS total score of >=15 at baseline
- •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
- •Patients and their partners can practice contraception at the end of follow-up observation period or by 1 week after the end of treatment
排除标准
- •Patients who have previously participated in a clinical trial of SPM962 and taken the investigational product (IP)
- •Patients with secondary RLS induced by renal impairment (uremia), iron deficiency anemia, drugs, pregnancy, etc.
- •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
- •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
- •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
- •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
- •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
- •Patients who have a history of epilepsy, convulsion, etc
- •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)
- •Patients with arrhythmia who have been taking Class 1a antiarrhythmic drugs (eg., quinidine, procainamide) or Class 3 antiarrhythmic drugs (eg., amiodarone, sotalol)
- •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)
- •Patients with congenital long QT syndrome
- •Patients whose serum potassium level is < 3.5mEq/L at the screening test
- •Patients whose total bilirubin 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
- •Patients whose BUN level is >= 30mg/dL, or whose serum creatinine level is >= 2.0mg/dL at the screening test
- •Patients who have a history of allergy to topical agents such as transdermal patch
- •Patients who are pregnant or nursing or who wish to become pregnant during the study period
- •Patients who habitually drink alcohol or smoke excessively
- •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
- •Patients who engage in hazardous work such as driving a vehicle, operating machinery, or working in a high location.
- •Patients with autoimmune disease, chronic active hepatitis, or immune deficiency disorder
- •Patients who have a complication or history of malignant neoplastic disease, or received treatment for the disease within 12 months prior to the screening test
- •Patients who are unable to properly record information in a patient diary
- •Patients who received other IPs within 12 weeks prior to commencement of study treatment
- •Patients who have been judged by the investigator or the sub-investigator to be inappropriate for inclusion in the study for any other reasons
研究组 & 干预措施
SPM 962 6.75
Experimental
started at 2.25 mg/day to 6.75 mg/day for 13 weeks
干预措施: SPM 962 (Drug)
SPM 962 4.5
Experimental
started at 2.25 mg/day to 4.5 mg/day for 13 weeks
干预措施: SPM 962 (Drug)
placebo
Placebo Comparator
for 13 weeks
干预措施: Placebo of SPM 962 (Drug)
结局指标
主要结局
International Restless Legs Syndrome Rating Scale (IRLS) Total Score
时间窗: Baseline, the end of dose-titration/dose-maintenance period (week 13)
Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.
次要结局
- Each Item of IRLS (10 Items)(Baseline, the end of dose-titration/dose-maintenance period (week 13))
- Incidence of RLS Symptoms(Baseline, the end of dose-titration/dose-maintenance period (week 13))
- Nocturnal Awakenings Due to RLS Symptoms in a Week(Baseline, the end of dose-titration/dose-maintenance period (week 13))
- Average Sleep Time in a Week(Baseline, the end of dose-titration/dose-maintenance period (weeks 13))
- Clinical Global Impression (CGI) Improvement(Baseline, the end of dose-titration/dose-maintenance period (week 13))
- Patient Global Impression (PGI) Improvement(Baseline, the end of dose-titration/dose-maintenance period (week 13))
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline, the end of dose-titration/dose-maintenance period (week 13))
- Average Duration of RLS Symptoms(Baseline, the end of dose-titration/dose-maintenance period (weeks 13))
- Average Duration of RLS Symptoms in the Evening and Night in a Week(Baseline, the end of dose-titration/dose-maintenance period (weeks 13))
- Incidence of RLS Symptoms in the Evening and Night(Baseline, the end of dose-titration/dose-maintenance period (week 13))
研究者
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