Trial · NCT01631825

A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients

NCT01631825, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-03-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients. Trials, record NCT01631825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01631825

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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 of SPM 962 in Advanced Parkinson's Disease Patients
NCT number: NCT01631825
Status: Completed
Phases: Phase 3
Enrollment: 321 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Parkinson's Disease
Interventions: SPM 962
First posted: 2012-06-29
Last updated: 2014-03-19
Results first posted: 2014-03-19

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	Up to 55 weeks after dosing	The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, 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 Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score	Baseline, Up to 54 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state). 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 2 Sum Score (Average of on State and Off State)	Baseline, up to 54 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state). UPDRS sub-scale Part 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	Absolute Time Spent "Off"	Baseline, up to 54 weeks after dosing	Mean number of hours in "off state" during a 24-hour period.
Secondary	UPDRS Part 1 Sum Score	Baseline, up to 54 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 1 sum score. UPDRS sub-scale Part 1 assesses 4 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 (On State)	Baseline, up to 54 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.
Secondary	UPDRS Part 2 Sum Score (Off State)	Baseline, up to 54 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.
Secondary	UPDRS Part 4 Sum Score	Baseline, up to 54 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 4 sum score. UPDRS sub-scale Part 4 assesses 11 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	Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score	Baseline, up to 54 weeks after dosing	Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score. A decrease in the scores means improvement.
Secondary	The Modified Hoehn & Yahr Severity of Illness	Baseline, up to 54 weeks after dosing.	Change (LOCF) from baseline in the Modified Hoehn \& Yahr Severity of Illness. The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided. The data at week 52 is shown.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	Up to 55 weeks after dosing	Safety set (SS)	participants	NUMBER
SECONDARY	Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score	Baseline, Up to 54 weeks after dosing	Full analysis set (FAS), last observation carried forward (LOCF)	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score (Average of on State and Off State)	Baseline, up to 54 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	Absolute Time Spent Off	Baseline, up to 54 weeks after dosing	FAS subjects with measurable off time at baseline, LOCF	Hours	MEAN
SECONDARY	UPDRS Part 1 Sum Score	Baseline, up to 54 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score (On State)	Baseline, up to 54 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score (Off State)	Baseline, up to 54 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 4 Sum Score	Baseline, up to 54 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score	Baseline, up to 54 weeks after dosing	FAS, LOCF	Scores on a scale	MEAN
SECONDARY	The Modified Hoehn & Yahr Severity of Illness	Baseline, up to 54 weeks after dosing.	FAS, LOCF	Percentage of participants	NUMBER

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group127

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

Outcome	Group	Category	Value	Units
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Any AEs	311	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Treatment-related AEs	269	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	SAEs	34	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Treatment-related SAEs	6	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Severe AEs	16	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Discontinuation due to AEs	47	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	Death	1	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	AEs of special interest 1	7	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	AEs of special interest 2	4	participants
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	SPM 962	AEs of special interest 3	54	participants

1 to 10 of 127Source ClinicalTrials.gov

See all 127 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	321
Overall Study	COMPLETED	SPM 962	256
Overall Study	NOT COMPLETED	SPM 962	65

Source ClinicalTrials.gov

Adverse events62

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	31	321	38
other	Dental Caries	Gastrointestinal disorders	SPM 962	20	321	21
other	Vomiting	Gastrointestinal disorders	SPM 962	16	321	25
other	Constipation	Gastrointestinal disorders	SPM 962	13	321	13
other	Stomatitis	Gastrointestinal disorders	SPM 962	8	321	8
other	Application Site Reaction	General disorders	SPM 962	198	321	217
other	Application Site Pruritus	General disorders	SPM 962	12	321	13
other	Oedema Peripheral	General disorders	SPM 962	12	321	12
other	Application Site Erythema	General disorders	SPM 962	10	321	10
other	Nasopharyngitis	Infections and infestations	SPM 962	76	321	108

1 to 10 of 62Source ClinicalTrials.gov

See all 62 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	290	321
Total, serious adverse events	SPM 962	34	321

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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