Idiopathic Restless Legs SyndromePhase 2NCT00666965
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
A Phase 2 study testing SPM 962 in people with Idiopathic Restless Legs Syndrome, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.
Trial 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. 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
- 230 participants
- Where
- 8 sitesJapan
- Study dates
- Jun 2008to Aug 2009
- Phase
- Phase 2
- 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
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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.
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
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
Official title: A Placebo-Controlled Study for SPM 962 in RLS Patients
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
- Being tested
- SPM 962
- Keywords
- SPM 962, rotigotine, Idiopathic Restless Legs Syndrome, RLS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPM 962Drug
Also called rotigotine
transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | inactive placebo Receives: 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 Receives: 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 Receives: Drug: SPM 962 |
| 4 | Experimental | 6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets Receives: Drug: SPM 962 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, end of maintenance period at 6 weeks
Secondary outcomes (5)
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.
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
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.
Measured: Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
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.
Measured: Baseline, every two weeks
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.
Measured: Baseline, every two weeks
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.
Measured: Baseline, every two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Saito, Study director, New Product Evaluation Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666965
- Sponsor's protocol ID
- 243-07-003
- Status last verified
- Mar 2014
- First submitted
- 23 Apr 2008
- Last updated
- 25 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Study for SPM 962 in RLS Patients
- ClinicalTrials.gov ID
- NCT00666965
- Acronym / sponsor ID
- 243-07-003
- Conditions
- Idiopathic Restless Legs Syndrome
- Keywords
- SPM 962, rotigotine, Idiopathic Restless Legs Syndrome, RLS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Posted 25 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: SPM 962inactive placebo |
| 2 | Experimental | Drug: SPM 9622.25 mg first week: 2.25 mg 1 sheet plus placebo 1 sheet 2nd to 6th week :2.25mg 1 sheet plus placebo 2 sheets |
| 3 | Experimental | Drug: SPM 9624.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet |
| 4 | Experimental | Drug: SPM 9626.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPM 962Also: rotigotinetransdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks | Drug | 1, 2, 3, 4 |
Primary outcome
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
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.
5 secondary outcomes
Clinical Global Impression (CGI) Severity
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
Patient Global Impression (PGI) Improvement
Time frame: Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, every two weeks
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Time frame: Baseline, every two weeks
IRLS Each Parameter
Time frame: Baseline, every two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katsuhisa Saito study director
New Product Evaluation Development
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 21 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 25 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Apr 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2014.