Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)

NCT01084551 | Completed Phase 3 Results

• 2 other identifiers: 243-09-001JapicCTI-101053
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 8

Brief Summary

The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed parallel group comparison study. Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale (IRLS) total score from baseline to the end of the dose-maintenance period.

Conditions

Idiopathic Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• International Restless Legs Syndrome Rating Scale (IRLS) Total Score

  Change from the baseline to the end of dose-titration/dose-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, the end of dose-titration/dose-maintenance period (week 13)

Secondary Outcomes (10)

• Clinical Global Impression (CGI) Improvement

  Baseline, the end of dose-titration/dose-maintenance period (week 13)

• Patient Global Impression (PGI) Improvement

  Baseline, the end of dose-titration/dose-maintenance period (week 13)

• The Pittsburgh Sleep Quality Index (PSQI)

  Baseline, the end of dose-titration/dose-maintenance period (week 13)

• Each Item of IRLS (10 Items)

  Baseline, the end of dose-titration/dose-maintenance period (week 13)

• Incidence of RLS Symptoms

  Baseline, the end of dose-titration/dose-maintenance period (week 13)

Study Arms (3)

SPM 962 4.5

EXPERIMENTAL

started at 2.25 mg/day to 4.5 mg/day for 13 weeks

Drug: SPM 962

SPM 962 6.75

EXPERIMENTAL

started at 2.25 mg/day to 6.75 mg/day for 13 weeks

Drug: SPM 962

placebo

PLACEBO COMPARATOR

for 13 weeks

Drug: Placebo of SPM 962

Interventions

SPM 962 DRUG

once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks

SPM 962 4.5

Placebo of SPM 962 DRUG

once a daily transdermal administration for 13 weeks

placebo

Eligibility Criteria

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

You may qualify if:

• Patients whose condition has been diagnosed as RLS by meeting all 4 of the International Restless legs Syndrome Study Group/ National Institute of Health (IRLSSG/NIH) criteria
• Patients who meet any of the following criteria relating to RLS treatment:
• Patients who have never received treatment for RLS
• Patients who have received treatment for RLS in the past and responded to L-dopa or dopamine agonists (Response to other RLS medicines is irrelevant.)
• Patients who have an IRLS total score of \>=15 at baseline
• Patients who experience symptoms in the evening or during the night on at least two days a week within 14 days prior to commencement of study treatment
• Patients and their partners can practice contraception at the end of follow-up observation period or by 1 week after the end of treatment

You may not qualify if:

• Patients who have previously participated in a clinical trial of SPM962 and taken the investigational product (IP)
• Patients with secondary RLS induced by renal impairment (uremia), iron deficiency anemia, drugs, pregnancy, etc.
• Patients who currently suffer, are at risk of developing, or have a history of sleep disorder such as sleep apnea syndrome, narcolepsy, and sleep attacks/sudden onset of sleep
• Patients who have concomitant diseases or symptoms which may affect the symptoms of RLS, such as polyneuropathy (including diabetic neuropathy), akathisia, claudication, varicoses, muscle fasciculation, painful legs and moving toes syndrome, radiculopathy and folate deficiency
• Patients who have other CNS diseases such as Parkinson's disease, dementia, progressive supranuclear paresis, multisystem atrophy, Huntington's Chorea, amyotrophic lateral sclerosis, and Alzheimer's disease
• Patients who have psychiatric conditions such as confusion, hallucination, delusion, and excitation, or patients who have abnormal behavior such as delirium, obsessive compulsive disorder, and impulse control disorder at the time of the screening test or baseline examination
• Patients whose SBP declines by at least 30 mmHg from supine to standing position based on the orthostatic hypotension assessment, or patients who develop orthostatic hypotension at baseline
• Patients who have a history of epilepsy, convulsion, etc
• Patients who have complications or a history of serious cardiac diseases or arrhythmia (eg, congestive heart failure of class 3 or 4 in the NYHA classification, second or third degree atrioventricular block, complete left bundle branch block, sick sinus syndrome, ventricular fibrillation, myocardial infarction within 12 months prior to the screening test, or a complication of angina pectoris)
• Patients with arrhythmia who have been taking Class 1a antiarrhythmic drugs (eg., quinidine, procainamide) or Class 3 antiarrhythmic drugs (eg., amiodarone, sotalol)
• Patients who have a serious ECG abnormality at the screening test and at the baseline examination
• Patients who show QTc intervals exceeding 450 ms in both ECGs in the screening test
• Patients who have an average QTc interval from the two ECGs in the baseline assessment that exceeds 470 ms (for females) or 450 ms (for males)
• Patients with congenital long QT syndrome
• Patients whose serum potassium level is \< 3.5mEq/L at the screening test

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

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Related Publications (1)

• Inoue Y, Shimizu T, Hirata K, Uchimura N, Ishigooka J, Oka Y, Ikeda J, Tomida T, Hattori N; Rotigotine Trial Group. Efficacy and safety of rotigotine in Japanese patients with restless legs syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group study. Sleep Med. 2013 Nov;14(11):1085-91. doi: 10.1016/j.sleep.2013.07.007. Epub 2013 Aug 21.

  PMID: 24055212 DERIVED

Results Point of Contact

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

+81-3-6361-7366

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: March 4, 2010
• First Posted: March 10, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 5, 2014
• Results First Posted: June 5, 2014

Record last verified: 2014-05

Locations

JP (8)