Trial · NCT01084551
Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
NCT01084551, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-06-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of SPM 962 in Patients With Restless Legs Syndrome (RLS). Trials, record NCT01084551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01084551
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
- NCT number
- NCT01084551
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 284 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Idiopathic Restless Legs Syndrome
- Interventions
- SPM 962, SPM 962, Placebo of SPM 962
- First posted
- 2010-03-10
- Last updated
- 2014-06-05
- Results first posted
- 2014-06-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | International Restless Legs Syndrome Rating Scale (IRLS) Total Score | Baseline, the end of dose-titration/dose-maintenance period (week 13) | 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. |
| Secondary | Clinical Global Impression (CGI) Improvement | Baseline, the end of dose-titration/dose-maintenance period (week 13) | 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. |
| Secondary | Patient Global Impression (PGI) Improvement | Baseline, the end of dose-titration/dose-maintenance period (week 13) | 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. |
| Secondary | The Pittsburgh Sleep Quality Index (PSQI) | Baseline, the end of dose-titration/dose-maintenance period (week 13) | 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. |
| Secondary | Each Item of IRLS (10 Items) | Baseline, the end of dose-titration/dose-maintenance period (week 13) | 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. |
| Secondary | Incidence of RLS Symptoms | Baseline, the end of dose-titration/dose-maintenance period (week 13) | 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% |
| Secondary | Average Duration of RLS Symptoms | Baseline, the end of dose-titration/dose-maintenance period (weeks 13) | 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. |
| Secondary | Incidence of RLS Symptoms in the Evening and Night | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation \* 100%. |
| Secondary | Average Duration of RLS Symptoms in the Evening and Night in a Week | Baseline, the end of dose-titration/dose-maintenance period (weeks 13) | 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. |
| Secondary | Nocturnal Awakenings Due to RLS Symptoms in a Week | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation \* 100%. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | International Restless Legs Syndrome Rating Scale (IRLS) Total Score | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Full analysis set (FAS), last observation carried forward (LOCF) | Scores on a scale | MEAN |
| SECONDARY | Clinical Global Impression (CGI) Improvement | Baseline, the end of dose-titration/dose-maintenance period (week 13) | FAS, LOCF | Percentage of Participants | NUMBER |
| SECONDARY | Patient Global Impression (PGI) Improvement | Baseline, the end of dose-titration/dose-maintenance period (week 13) | FAS, LOCF | Percentage of Participants | NUMBER |
| SECONDARY | The Pittsburgh Sleep Quality Index (PSQI) | Baseline, the end of dose-titration/dose-maintenance period (week 13) | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | Each Item of IRLS (10 Items) | Baseline, the end of dose-titration/dose-maintenance period (week 13) | FAS, LOCF | percentage of participants | NUMBER |
| SECONDARY | Incidence of RLS Symptoms | Baseline, the end of dose-titration/dose-maintenance period (week 13) | FAS, LOCF | percentage of days with RLS symptom | MEAN |
| SECONDARY | Average Duration of RLS Symptoms | Baseline, the end of dose-titration/dose-maintenance period (weeks 13) | FAS, LOCF | Hours | MEAN |
| SECONDARY | Incidence of RLS Symptoms in the Evening and Night | Baseline, the end of dose-titration/dose-maintenance period (week 13) | FAS, LOCF | percentage of days/week with symptoms | MEAN |
| SECONDARY | Average Duration of RLS Symptoms in the Evening and Night in a Week | Baseline, the end of dose-titration/dose-maintenance period (weeks 13) | FAS, LOCF | Hours | MEAN |
| SECONDARY | Nocturnal Awakenings Due to RLS Symptoms in a Week | Baseline, the end of dose-titration/dose-maintenance period (week 13) | FAS, LOCF | percentage of days/week with awakening | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group105
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| International Restless Legs Syndrome Rating Scale (IRLS) Total Score | Placebo | -11.6 | Standard Deviation 8.2 | Scores on a scale | |
| International Restless Legs Syndrome Rating Scale (IRLS) Total Score | SPM 962 4.5 | -14.3 | Standard Deviation 8.9 | Scores on a scale | |
| International Restless Legs Syndrome Rating Scale (IRLS) Total Score | SPM 962 6.75 | -14.6 | Standard Deviation 9.0 | Scores on a scale | |
| Clinical Global Impression (CGI) Improvement | Placebo | Subjects with much improved | 24.2 | Percentage of Participants | |
| Clinical Global Impression (CGI) Improvement | SPM 962 4.5 | Subjects with much improved | 25.8 | Percentage of Participants | |
| Clinical Global Impression (CGI) Improvement | SPM 962 6.75 | Subjects with much improved | 29.0 | Percentage of Participants | |
| Clinical Global Impression (CGI) Improvement | Placebo | Subjects with very much improved | 33.7 | Percentage of Participants | |
| Clinical Global Impression (CGI) Improvement | SPM 962 4.5 | Subjects with very much improved | 41.9 | Percentage of Participants | |
| Clinical Global Impression (CGI) Improvement | SPM 962 6.75 | Subjects with very much improved | 45.2 | Percentage of Participants | |
| Patient Global Impression (PGI) Improvement | Placebo | Subjects with much improved | 23.2 | Percentage of Participants |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 95 | |
| Overall Study | STARTED | SPM 962 4.5 | 95 | |
| Overall Study | STARTED | SPM 962 6.75 | 94 | |
| Overall Study | COMPLETED | Placebo | 86 | |
| Overall Study | COMPLETED | SPM 962 4.5 | 81 | |
| Overall Study | COMPLETED | SPM 962 6.75 | 86 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | SPM 962 4.5 | 14 | |
| Overall Study | NOT COMPLETED | SPM 962 6.75 | 8 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ventricular Extrasystoles | Cardiac disorders | Placebo | 0 | 95 | 0 |
| other | Ventricular Extrasystoles | Cardiac disorders | SPM 962 4.5 | 0 | 95 | 0 |
| other | Ventricular Extrasystoles | Cardiac disorders | SPM 962 6.75 | 3 | 94 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 9 | 95 | 12 |
| other | Nausea | Gastrointestinal disorders | SPM 962 4.5 | 32 | 95 | 37 |
| other | Nausea | Gastrointestinal disorders | SPM 962 6.75 | 41 | 94 | 48 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 95 | 2 |
| other | Vomiting | Gastrointestinal disorders | SPM 962 4.5 | 4 | 95 | 5 |
| other | Vomiting | Gastrointestinal disorders | SPM 962 6.75 | 10 | 94 | 11 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo | 3 | 95 | 3 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | SPM 962 4.5 | ||
| Total, all-cause mortality | SPM 962 6.75 | ||
| Total, other adverse events | Placebo | 32 | 95 |
| Total, other adverse events | SPM 962 4.5 | 72 | 95 |
| Total, other adverse events | SPM 962 6.75 | 77 | 94 |
| Total, serious adverse events | Placebo | 2 | 95 |
| Total, serious adverse events | SPM 962 4.5 | 0 | 95 |
| Total, serious adverse events | SPM 962 6.75 | 1 | 94 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24055212 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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