Trial · NCT01628926

A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

NCT01628926, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients. Trials, record NCT01628926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01628926

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Trial

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

Title: A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients
NCT number: NCT01628926
Status: Completed
Phases: Phase 3
Enrollment: 420 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Parkinson's Disease
Interventions: SPM 962, Ropinirole, Placebo
First posted: 2012-06-27
Last updated: 2014-05-23
Results first posted: 2014-05-23

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score	baseline, 16 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing. UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Secondary	UPDRS Part 3 Sum Score	baseline, 8 and 10 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing. UPDRS Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Secondary	UPDRS Part 2 Sum Score	Baseline, 16 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing. UPDRS 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Secondary	Off Time	Baseline, 16 weeks after dosing	Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.
Secondary	Parkinson's Disease Sleep Scale-2 (PDSS-2)	Baseline, 16 weeks after dosing	Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.
Secondary	On Time	Baseline, 16 weeks after dosing	Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Secondary	On Time Without Dyskinesia Disturbing Daily Activities	Baseline, 16 weeks after dosing	Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Secondary	On Time With Dyskinesia Disturbing Daily Activities	Baseline, 16 weeks after dosing	Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).
Secondary	Effective Rate in UPDRS Part 3 Sum Score	Baseline, 16 weeks after dosing	Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.
Secondary	Effective Rate in UPDRS Part 2 Sum Score	Baseline, 16 weeks after dosing	Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score	baseline, 16 weeks after dosing	Full analysis set (FAS), last observation carried forward (LOCF)	Scores on a scale	MEAN
SECONDARY	UPDRS Part 3 Sum Score	baseline, 8 and 10 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score	Baseline, 16 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	Off Time	Baseline, 16 weeks after dosing	FAS subjects with measurable off time data at baseline, LOCF	Hours/day	MEAN
SECONDARY	Parkinson's Disease Sleep Scale-2 (PDSS-2)	Baseline, 16 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	On Time	Baseline, 16 weeks after dosing	FAS, LOCF	Hours/day	MEAN
SECONDARY	On Time Without Dyskinesia Disturbing Daily Activities	Baseline, 16 weeks after dosing	FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance.	Hours/day	MEAN
SECONDARY	On Time With Dyskinesia Disturbing Daily Activities	Baseline, 16 weeks after dosing	FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period.	Hours	MEAN
SECONDARY	Effective Rate in UPDRS Part 3 Sum Score	Baseline, 16 weeks after dosing	FAS, LOCF	Percentage of participants	NUMBER
SECONDARY	Effective Rate in UPDRS Part 2 Sum Score	Baseline, 16 weeks after dosing	FAS, LOCF	Percentage of participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group81

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

Outcome	Group	Category	Value	Spread	Units
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score	SPM 962		-10.9	Standard Deviation 8.1	Scores on a scale
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score	Ropinirole		-9.5	Standard Deviation 8.7	Scores on a scale
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score	Placebo		-4.5	Standard Deviation 9.7	Scores on a scale
UPDRS Part 3 Sum Score	SPM 962	8 weeks after dosing	-9.7	Standard Deviation 7.2	Scores on a scale
UPDRS Part 3 Sum Score	Ropinirole	8 weeks after dosing	-8.4	Standard Deviation 8.1	Scores on a scale
UPDRS Part 3 Sum Score	Placebo	8 weeks after dosing	-5.5	Standard Deviation 8.3	Scores on a scale
UPDRS Part 3 Sum Score	SPM 962	10 weeks after dosing	-9.9	Standard Deviation 7.1	Scores on a scale
UPDRS Part 3 Sum Score	Ropinirole	10 weeks after dosing	-8.8	Standard Deviation 8.3	Scores on a scale
UPDRS Part 3 Sum Score	Placebo	10 weeks after dosing	-5.3	Standard Deviation 9.0	Scores on a scale
UPDRS Part 2 Sum Score	SPM 962		-3.6	Standard Deviation 4.1	Scores on a scale

1 to 10 of 81Source ClinicalTrials.gov

See all 81 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SPM 962	168
Overall Study	STARTED	Ropinirole	167
Overall Study	STARTED	Placebo	85
Overall Study	COMPLETED	SPM 962	142
Overall Study	COMPLETED	Ropinirole	144
Overall Study	COMPLETED	Placebo	68
Overall Study	NOT COMPLETED	SPM 962	26
Overall Study	NOT COMPLETED	Ropinirole	23
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events105

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	25	168	27
other	Nausea	Gastrointestinal disorders	Ropinirole	23	167	26
other	Nausea	Gastrointestinal disorders	Placebo	7	85	8
other	Vomiting	Gastrointestinal disorders	SPM 962	11	168	15
other	Vomiting	Gastrointestinal disorders	Ropinirole	11	167	13
other	Vomiting	Gastrointestinal disorders	Placebo	2	85	2
other	Application Site Reaction	General disorders	SPM 962	91	168	93
other	Application Site Reaction	General disorders	Ropinirole	30	167	33
other	Application Site Reaction	General disorders	Placebo	10	85	11
other	Application Site Pruritus	General disorders	SPM 962	6	168	7

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SPM 962
Total, all-cause mortality	Ropinirole
Total, all-cause mortality	Placebo
Total, other adverse events	SPM 962	140	168
Total, other adverse events	Ropinirole	99	167
Total, other adverse events	Placebo	40	85
Total, serious adverse events	SPM 962	7	168
Total, serious adverse events	Ropinirole	5	167
Total, serious adverse events	Placebo	6	85

Source ClinicalTrials.gov

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.

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