Trial · NCT01562743

A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome

NCT01562743, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-04-23

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome. Trials, record NCT01562743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01562743

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Trial

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

Title: A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
NCT number: NCT01562743
Status: Completed
Phases: Phase 2
Enrollment: 185 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Idiopathic Restless Legs Syndrome
Interventions: SPM 962
First posted: 2012-03-26
Last updated: 2014-04-23
Results first posted: 2014-04-23

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	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
Primary	Augmentation	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).
Primary	Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit	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.
Secondary	Change of IRLS Sum Score From the Baseline to Each Visit	Baseline, Up to 53 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	Efficacy Rate in IRLS Sum Score	Baseline, Up to 53 weeks	Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
Secondary	Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit	Baseline, Up to 52 weeks	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.
Secondary	Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit	Baseline, Up to 53 weeks	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.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	Up to 54 weeks	Safety set (SS)	participants	NUMBER
PRIMARY	Augmentation	Up to 53 weeks	SS	participants	NUMBER
SECONDARY	Change of IRLS Sum Score From the Baseline to Each Visit	Baseline, Up to 53 weeks	Full analysis set (FAS), last observation carried forward (LOCF)	Scores on a scale	MEAN
SECONDARY	Efficacy Rate in IRLS Sum Score	Baseline, Up to 53 weeks	FAS, LOCF	Percentage of participants	NUMBER
SECONDARY	Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit	Baseline, Up to 52 weeks	FAS, LOCF	Scores on a scale	MEAN
PRIMARY	Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit	Baseline, Up to 53 weeks	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit	Baseline, Up to 53 weeks	FAS, LOCF	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group35

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

Outcome	Group	Category	Value	Units
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Any AEs	175	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Treatment-related AEs	139	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	SAEs	5	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Treatment-related SAEs	1	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Severe AEs	3	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Discontinuation due to AEs	29	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Death	0	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	AEs of special interest 1	0	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	AEs of special interest 2	0	participants
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	AEs of special interest 3	0	participants

1 to 10 of 35Source ClinicalTrials.gov

See all 35 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SPM 962	185
Overall Study	COMPLETED	SPM 962	133
Overall Study	NOT COMPLETED	SPM 962	52

Source ClinicalTrials.gov

Adverse events26

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	Nausea	Gastrointestinal disorders	SPM 962	53	185	79
other	Vomiting	Gastrointestinal disorders	SPM 962	15	185	26
other	Diarrhoea	Gastrointestinal disorders	SPM 962	12	185	12
other	Abdominal Pain Upper	Gastrointestinal disorders	SPM 962	10	185	11
other	Application Site Reaction	General disorders	SPM 962	85	185	94
other	Application Site Pruritus	General disorders	SPM 962	12	185	13
other	Application Site Erythema	General disorders	SPM 962	6	185	6
other	Nasopharyngitis	Infections and infestations	SPM 962	97	185	186
other	Influenza	Infections and infestations	SPM 962	6	185	6
other	Fall	Injury, poisoning and procedural complications	SPM 962	11	185	11

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SPM 962
Total, other adverse events	SPM 962	165	185
Total, serious adverse events	SPM 962	5	185

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23103551	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.

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.

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