- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00666965
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
A Placebo-Controlled Study for SPM 962 in RLS Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Chubu region, Japan
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Chugoku region, Japan
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Hokkaido region, Japan
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Kanto region, Japan
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Kinki region, Japan
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Kyushu region, Japan
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Shikoku region, Japan
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Tohoku region, Japan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 1
inactive placebo
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transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Names:
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Experimental: 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
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transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Names:
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Experimental: 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
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transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Names:
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Experimental: 4
6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets
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transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period
Time Frame: Baseline, end of maintenance period at 6 weeks
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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. |
Baseline, end of maintenance period at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression (CGI) Severity
Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
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CGI is a clinician-reported scale for assessing severity of illness. The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients. |
Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
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Patient Global Impression (PGI) Improvement
Time Frame: Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
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The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention.
Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.
Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7.
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Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
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The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, every two weeks
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PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty". A decrease in the scores means improvement. The data at 6 weeks after dosing is shown. |
Baseline, every two weeks
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Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Time Frame: Baseline, every two weeks
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Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing.
SF-36 is a scale for assessing health status in clinical practice and research.
The scores of 36 questions are summarized into 7 sub-scales.
In each sub-scale which range is 0-100, a higher score indicates a better health status.
Thus a increase in the scores means improvement.
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Baseline, every two weeks
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IRLS Each Parameter
Time Frame: Baseline, every two weeks
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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. The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown. |
Baseline, every two weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Katsuhisa Saito, New Product Evaluation Development
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Syndrome
- Psychomotor Agitation
- Restless Legs Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agonists
- Dopamine Agents
- Rotigotine
Other Study ID Numbers
- 243-07-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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