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Idiopathic Restless Legs SyndromePhase 3NCT01084551

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

A Phase 3 study testing SPM 962 in people with Idiopathic Restless Legs Syndrome, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Idiopathic Restless Legs Syndrome
What is being tested?
SPM 962
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
284 participants
Where
8 sitesJapan
Study dates
Feb 2010to Sep 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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
  • Patients whose total bilirubin is >= 3.0mg/dL, or whose AST(GOT) and ALT(GPT) are equal or more than 2.5 times the reference range of the clinical site (or >= 100IU/L) at the screening test
  • Patients whose BUN level is >= 30mg/dL, or whose serum creatinine level is >= 2.0mg/dL at the screening test
  • Patients who have a history of allergy to topical agents such as transdermal patch
  • Patients who are pregnant or nursing or who wish to become pregnant during the study period
  • Patients who habitually drink alcohol or smoke excessively
  • Patients who engage in evening shift work or other such shift work, or whose work or circumstances makes it difficult to maintain a regular period of sleep
  • Patients who engage in hazardous work such as driving a vehicle, operating machinery, or working in a high location.
  • Patients with autoimmune disease, chronic active hepatitis, or immune deficiency disorder
  • Patients who have a complication or history of malignant neoplastic disease, or received treatment for the disease within 12 months prior to the screening test
  • Patients who are unable to properly record information in a patient diary
  • Patients who received other IPs within 12 weeks prior to commencement of study treatment
  • Patients who have been judged by the investigator or the sub-investigator to be inappropriate for inclusion in the study for any other reasons

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Study site

    Chubu Region

  • Study site

    Chugoku Region

  • Study site

    Hokkaido Region

  • Study site

    Kansai Region

  • Study site

    Kanto Region

  • Study site

    Kyushu Region

  • Study site

    Shikoku Region

  • Study site

    Tohoku Region

Other trials in Japan

About this study

Official title: A Phase 3 Multi-Center, Placebo-Controlled, Double Blind, 3-Armed Parallel Group, Comparative Study of SPM 962 4.5 and 6.75 mg/Day to Investigate Superiority to Placebo in Patients With Restless Legs Syndrome

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.

Being tested
SPM 962, Placebo of SPM 962

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPM 962Drug

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

  • SPM 962Drug

    once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks

  • Placebo of SPM 962Drug

    once a daily transdermal administration for 13 weeks

Study groups in NCT01084551
Study groupRoleWhat they receive
SPM 962 4.5Experimentalstarted at 2.25 mg/day to 4.5 mg/day for 13 weeks
Receives: Drug: SPM 962
SPM 962 6.75Experimentalstarted at 2.25 mg/day to 6.75 mg/day for 13 weeks
Receives: Drug: SPM 962
placeboPlacebo comparatorfor 13 weeks
Receives: Drug: Placebo of SPM 962

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  1. Clinical Global Impression (CGI) Improvement

    CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.

    The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse.

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

  2. Patient Global Impression (PGI) Improvement

    PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline.

    The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse.

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

  3. The Pittsburgh Sleep Quality Index (PSQI)

    Change of PSQI from baseline to the end of dose-titration/dose-maintenance period.

    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.

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

  4. Each Item of IRLS (10 Items)

    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).

    Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement.

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

  5. Incidence of RLS Symptoms

    Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week* 100%

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

  6. Average Duration of RLS Symptoms

    Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.

    Measured: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)

  7. Incidence of RLS Symptoms in the Evening and Night

    Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation * 100%.

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

  8. Average Duration of RLS Symptoms in the Evening and Night in a Week

    Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.

    Measured: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)

  9. Nocturnal Awakenings Due to RLS Symptoms in a Week

    Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation * 100%.

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

  10. Average Sleep Time in a Week

    Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period.

    Measured: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01084551
Sponsor's protocol ID
243-09-001
Other IDs
JapicCTI-101053
Status last verified
May 2014
First submitted
4 Mar 2010
Last updated
5 Jun 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 24055212

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPM 962 in people with Idiopathic Restless Legs Syndrome, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Restless Legs Syndrome Rating Scale (IRLS) Total Score (time frame: Baseline, the end of dose-titration/dose-maintenance period (week 13)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01084551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.

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