A Placebo-Controlled Study for SPM 962 in RLS Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
- 主要终点
- Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period
研究概览
简要总结
The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.
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
- •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
排除标准
- •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.
研究组 & 干预措施
1
inactive placebo
干预措施: SPM 962 (Drug)
2
2.25 mg first week: 2.25 mg 1 sheet plus placebo 1 sheet 2nd to 6th week :2.25mg 1 sheet plus placebo 2 sheets
干预措施: SPM 962 (Drug)
3
4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet
干预措施: SPM 962 (Drug)
4
6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets
干预措施: SPM 962 (Drug)
结局指标
主要结局
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period
时间窗: Baseline, end of maintenance period at 6 weeks
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
- Patient Global Impression (PGI) Improvement(Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.)
- IRLS Each Parameter(Baseline, every two weeks)
- Clinical Global Impression (CGI) Severity(Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.)
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline, every two weeks)
- Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)(Baseline, every two weeks)