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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00666965
First received: April 23, 2008
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Idiopathic Restless Legs Syndrome
Drug: SPM 962
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Study for SPM 962 in RLS Patients

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

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 [ Time Frame: Baseline, end of maintenance period at 6 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every two weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 230
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
inactive placebo
Drug: SPM 962
transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Name: rotigotine
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
Drug: SPM 962
transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Name: rotigotine
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
Drug: SPM 962
transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Name: rotigotine
Experimental: 4
6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets
Drug: SPM 962
transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other Name: rotigotine

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666965

Locations
Japan
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Shikoku region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito New Product Evaluation Development
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00666965     History of Changes
Other Study ID Numbers: 243-07-003
Study First Received: April 23, 2008
Results First Received: February 3, 2014
Last Updated: March 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
SPM 962
rotigotine
Idiopathic Restless Legs Syndrome
RLS

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Dyskinesias
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Parasomnias
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014