Idiopathic Restless Legs SyndromePhase 2RLSNCT01562743
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
A Phase 2 study testing SPM 962 in people with Idiopathic Restless Legs Syndrome, run by Otsuka Pharmaceutical Co., Ltd..
Trial summary
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. 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?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Oct 2010
- 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 completed the preceding trial 243-07-003 (NCT00666965)
Who cannot join
- Subject discontinued from the preceding trial 243-07-003 (NCT00666965)
- Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003
- Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003.
- Subject had persistent hallucination or delusion during trial 243-07-003.
- Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
- Subject had orthostatic hypotension or a systolic blood pressure (SBP) ≤ 100 mmHg and had a decrease of SBP from spine to standing position ≥ 30 mmHg at baseline.
Show all 14Show fewer
- Subject had a history of epilepsy, convulsion etc. during trial 243-07-003.
- Subject developed serious ECG abnormality at the baseline.
- Subject had QTc-interval ≥ 500 msec at the baseline or subject had an increase of QTc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
- Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-003.
- Subject had a total bilirubin ≥ 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ≥ 100 IU/L) at the end of the period in trial 243-07-003.
- Subject had BUN ≥ 30 mg/dL or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-003.
- Subject who planned pregnancy during the trial.
- Subject was judged to be inappropriate for this trial by the investigator for the reasons other than above.
About this study
Official title: An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.
- Conditions
- Idiopathic Restless Legs Syndrome
- Being tested
- SPM 962
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPM 962Drug
Also called rotigotine
Tansdermal patch
| Study group | Role | What they receive |
|---|---|---|
| SPM 962 | Experimental | Rotigotine transdermal patch Receives: Drug: SPM 962 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters.
AEs of special interest (1-3) are defined as below:
- sudden onset of sleep
- obsessive-compulsive disorder or impulse-control disorder
- hallucination, delusion
Measured: Up to 54 weeks
Augmentation
Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity.
Augmentation is clinically significant when at least one of the following occurs:
- Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;
- Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation;
- Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose);
- Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity);
- Any other aspect as judged by the evaluator (should be specified).
Measured: Up to 53 weeks
Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
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, Up to 53 weeks
Secondary outcomes (4)
Change of IRLS Sum Score From the Baseline to Each Visit
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, Up to 53 weeks
Efficacy Rate in IRLS Sum Score
Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
Measured: Baseline, Up to 53 weeks
Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24).
A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Measured: Baseline, Up to 52 weeks
Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
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, Up to 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startAug 2008
- Primary completionOct 2010
- Study completionOct 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562743
- Sponsor's protocol ID
- 243-07-004
- Acronym
- RLS
- Status last verified
- Mar 2014
- First submitted
- 22 Mar 2012
- Last updated
- 23 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Inoue Y, Hirata K, Hayashida K, Hattori N, Tomida T, Garcia-Borreguero D; Rotigotine Study Group. Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Jan 10;40:326-33. doi: 10.1016/j.pnpbp.2012.10.012. Epub 2012 Oct 25.
PubMed 23103551
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT01562743
- Acronym / sponsor ID
- RLS / 243-07-004
- Conditions
- Idiopathic Restless Legs Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Posted 23 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 aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPM 962 | Experimental | Drug: SPM 962Rotigotine transdermal patch |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject completed the preceding trial 243-07-003 (NCT00666965)
Key exclusion criteria (14 listed)
- Subject discontinued from the preceding trial 243-07-003 (NCT00666965)
- Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003
- Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003.
- Subject had persistent hallucination or delusion during trial 243-07-003.
- Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
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: rotigotineTansdermal patch | Drug | SPM 962 |
Primary outcome
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Time frame: Up to 54 weeks
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion
Augmentation
Time frame: Up to 53 weeks
Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity. Augmentation is clinically significant when at least one of the following occurs: 1. Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation; 2. Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation; 3. Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose); 4. Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity); 5. Any other aspect as judged by the evaluator (should be specified).
Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
Time frame: Baseline, Up to 53 weeks
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.
4 secondary outcomes
Change of IRLS Sum Score From the Baseline to Each Visit
Time frame: Baseline, Up to 53 weeks
Efficacy Rate in IRLS Sum Score
Time frame: Baseline, Up to 53 weeks
Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
Time frame: Baseline, Up to 52 weeks
Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
Time frame: Baseline, Up to 53 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23103551Inoue Y, Hirata K, Hayashida K, Hattori N, Tomida T, Garcia-Borreguero D; Rotigotine Study Group. Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Jan 10;40:326-33. doi: 10.1016/j.pnpbp.2012.10.012. Epub 2012 Oct 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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..
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 1 inclusion and 14 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 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 23 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?
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters (time frame: Up to 54 weeks). The study lists 3 primary outcomes in all. 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 NCT01562743, 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 23 Apr 2014.