Status:
COMPLETED
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Idiopathic Restless Legs Syndrome
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
Brief Summary
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 follo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 19\. Subject received an investigational drug from other clinical trial within the last 12 months prior to baseline.
- 20\. Subject is judged to be inappropriate for this trial by investigator on the other than above.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00666965
Start Date
June 1 2008
End Date
August 1 2009
Last Update
April 25 2014
Active Locations (8)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan