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A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients

Primary Purpose

Idiopathic Restless Legs Syndrome

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SPM 962
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Restless Legs Syndrome focused on measuring SPM 962, rotigotine, Idiopathic Restless Legs Syndrome, RLS

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical features according to the IRLSSG/NIH.
  3. 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.
  4. 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)
  5. Subject has a score of ≧ 4 on the CGI Severity score at baseline

Exclusion Criteria:

  1. Subject has secondary RLS in association with renal impairment such as uremia,iron deficiency anemia, and drug associated symptoms.
  2. 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.
  3. 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.
  4. 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.
  5. At screening or baseline, subject has psychiatric condition like confusion, hallucination, delusion, excitation, deliria, abnormal behaviour.
  6. 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.
  7. Subject has a history of epilepsy, convulsion etc.
  8. 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).
  9. Subject has arrhythmia and receiving Class Ia antiarrhythmic drugs(e.g., quinidine, procainamide), Class III antiarrhythmic drugs (e.g., amiodarone, sotalol)
  10. 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.
  11. Subject has long QT syndrome congenital.
  12. Subject has a serum potassium level < 3.5 mEq/L at screening.
  13. 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.
  14. Subject has BUN ≧ 30 mg/dL or serum creatinine ≧2.0 mg/dl at screening.
  15. Subject has a history of allergic reaction to topical agents such as transdermal patch.
  16. Subject is pregnant or nursing or woman who plans pregnancy during the trial.
  17. Subject pursues shift work or is subject to other continuous non-disease-related life conditions which do not allow regular sleep at night.
  18. Subject has autoimmune disease, chronic active hepatitis or immune deficiency disorder.
  19. 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

inactive placebo

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

4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet

6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets

Outcomes

Primary Outcome Measures

Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/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.

Secondary Outcome Measures

Clinical Global Impression (CGI) Severity
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.
Patient Global Impression (PGI) Improvement
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.
The Pittsburgh Sleep Quality Index (PSQI)
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.
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
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.
IRLS Each Parameter
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.

Full Information

First Posted
April 23, 2008
Last Updated
March 26, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00666965
Brief Title
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
Official Title
A Placebo-Controlled Study for SPM 962 in RLS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Restless Legs Syndrome
Keywords
SPM 962, rotigotine, Idiopathic Restless Legs Syndrome, RLS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
inactive placebo
Arm Title
2
Arm Type
Experimental
Arm Description
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
Arm Title
3
Arm Type
Experimental
Arm Description
4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet
Arm Title
4
Arm Type
Experimental
Arm Description
6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets
Intervention Type
Drug
Intervention Name(s)
SPM 962
Other Intervention Name(s)
rotigotine
Intervention Description
transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Primary Outcome Measure Information:
Title
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period
Description
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.
Time Frame
Baseline, end of maintenance period at 6 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI) Severity
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
Title
Patient Global Impression (PGI) Improvement
Description
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.
Time Frame
Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
Title
The Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline, every two weeks
Title
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Description
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.
Time Frame
Baseline, every two weeks
Title
IRLS Each Parameter
Description
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.
Time Frame
Baseline, every two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
New Product Evaluation Development
Official's Role
Study Director
Facility Information:
City
Chubu region
Country
Japan
City
Chugoku region
Country
Japan
City
Hokkaido region
Country
Japan
City
Kanto region
Country
Japan
City
Kinki region
Country
Japan
City
Kyushu region
Country
Japan
City
Shikoku region
Country
Japan
City
Tohoku region
Country
Japan

12. IPD Sharing Statement

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A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients

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