Trial · NCT00666965

A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients

NCT00666965, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-04-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients. Trials, record NCT00666965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666965

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
NCT number: NCT00666965
Status: Completed
Phases: Phase 2
Enrollment: 230 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Idiopathic Restless Legs Syndrome
Interventions: SPM 962
First posted: 2008-04-25
Last updated: 2014-04-25
Results first posted: 2014-04-25

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period	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.
Secondary	Clinical Global Impression (CGI) Severity	Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.	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.
Secondary	Patient Global Impression (PGI) Improvement	Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.	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.
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	Baseline, every two 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. The data at 6 weeks after dosing is shown.
Secondary	Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)	Baseline, every two weeks	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.
Secondary	IRLS Each Parameter	Baseline, every two 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. The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period	Baseline, end of maintenance period at 6 weeks	Full analysis set (FAS), last observation carried forward (LOCF)	scores on a scale	MEAN
SECONDARY	Clinical Global Impression (CGI) Severity	Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.	FAS, LOCF	Percentage of Participants	NUMBER
SECONDARY	Patient Global Impression (PGI) Improvement	Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.	FAS, LOCF	Percentage of Participants	NUMBER
SECONDARY	The Pittsburgh Sleep Quality Index (PSQI)	Baseline, every two weeks	FAS, LOCF	Percentage of Participants	NUMBER
SECONDARY	Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)	Baseline, every two weeks	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	IRLS Each Parameter	Baseline, every two weeks	FAS, LOCF	Percentage of Participants	NUMBER

Source ClinicalTrials.gov

Results by group160

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period	Placebo		-9.8	Standard Deviation 7.2	scores on a scale
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period	2.25 mg/Day		-10.7	Standard Deviation 6.3	scores on a scale
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period	4.5 mg/Day		-14.4	Standard Deviation 7.2	scores on a scale
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period	6.75 mg/Day		-14.1	Standard Deviation 8.8	scores on a scale
Clinical Global Impression (CGI) Severity	Placebo	Decreased	73.7		Percentage of Participants
Clinical Global Impression (CGI) Severity	2.25 mg/Day	Decreased	83.6		Percentage of Participants
Clinical Global Impression (CGI) Severity	4.5 mg/Day	Decreased	92.9		Percentage of Participants
Clinical Global Impression (CGI) Severity	6.75 mg/Day	Decreased	86.3		Percentage of Participants
Clinical Global Impression (CGI) Severity	Placebo	Increased	1.8		Percentage of Participants
Clinical Global Impression (CGI) Severity	2.25 mg/Day	Increased	1.8		Percentage of Participants

1 to 10 of 160Source ClinicalTrials.gov

See all 160 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	58
Overall Study	STARTED	2.25 mg/Day	57
Overall Study	STARTED	4.5 mg/Day	58
Overall Study	STARTED	6.75 mg/Day	57
Overall Study	COMPLETED	Placebo	55
Overall Study	COMPLETED	2.25 mg/Day	53
Overall Study	COMPLETED	4.5 mg/Day	56
Overall Study	COMPLETED	6.75 mg/Day	42
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	2.25 mg/Day	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events96

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	Vertigo	Ear and labyrinth disorders	Placebo	0	58	0
other	Vertigo	Ear and labyrinth disorders	2.25 mg/Day	0	57	0
other	Vertigo	Ear and labyrinth disorders	4.5 mg/Day	0	58	0
other	Vertigo	Ear and labyrinth disorders	6.75 mg/Day	2	57	2
other	Photopsia	Eye disorders	Placebo	0	58	0
other	Photopsia	Eye disorders	2.25 mg/Day	0	57	0
other	Photopsia	Eye disorders	4.5 mg/Day	2	58	2
other	Photopsia	Eye disorders	6.75 mg/Day	0	57	0
other	Nausea	Gastrointestinal disorders	Placebo	8	58	10
other	Nausea	Gastrointestinal disorders	2.25 mg/Day	19	57	19

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	2.25 mg/Day
Total, all-cause mortality	4.5 mg/Day
Total, all-cause mortality	6.75 mg/Day
Total, other adverse events	Placebo	29	58
Total, other adverse events	2.25 mg/Day	37	57
Total, other adverse events	4.5 mg/Day	50	58
Total, other adverse events	6.75 mg/Day	44	57
Total, serious adverse events	Placebo	0	58
Total, serious adverse events	2.25 mg/Day	0	57

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00666965

GET https://conductscience.org/api/trials/v1/NCT00666965/results?page=2

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