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

NCT00666965 | Completed Phase 2 Results

• 1 other identifier: 243-07-003
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 8

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.

Conditions

Idiopathic Restless Legs Syndrome

Keywords

SPM 962; rotigotine; Idiopathic Restless Legs Syndrome; RLS

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, end of maintenance period at 6 weeks

Secondary Outcomes (5)

• Clinical Global Impression (CGI) Severity

  Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.

• Patient Global Impression (PGI) Improvement

  Baseline, 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

• IRLS Each Parameter

  Baseline, every two weeks

Study Arms (4)

1

PLACEBO COMPARATOR

inactive placebo

Drug: SPM 962

2

EXPERIMENTAL

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

3

EXPERIMENTAL

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

4

EXPERIMENTAL

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

Drug: SPM 962

Interventions

SPM 962 DRUG

transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks

Also known as: rotigotine

1; 2; 3; 4

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Interventions

rotigotine

Results Point of Contact

• Title: Director of Clinical Research and Development
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7366

Study Officials

• Katsuhisa Saito

  New Product Evaluation Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 25, 2014
• Results First Posted: April 25, 2014

Record last verified: 2014-03

Locations

JP (8)