Trial · NCT01631812

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

NCT01631812, Phase 2, 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 Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients. Trials, record NCT01631812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01631812

On this page

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 Advanced Parkinson's Disease Patients
NCT number: NCT01631812
Status: Completed
Phases: Phase 2
Enrollment: 130 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 outcomes5

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

List	Outcome	Time frame	Description
Primary	Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	Up to 55 weeks after dosing	Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing. \*decrease in difference between supine and standing systolic blood pressure
Primary	Skin Irritation Score of the Application Site	Up to 55 weeks after dosing	Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis. -: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum
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) up to 54 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 2 Sum Score	Baseline, Up to 54 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 weeks after dosing 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"	Up to 54 weeks after dosing	Mean number of hours in "off state" during a 24-hour period.

Source ClinicalTrials.gov

Outcomes5

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, 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	Baseline, Up to 54 weeks after dosing		Scores on a scale	MEAN
SECONDARY	Absolute Time Spent Off	Up to 54 weeks after dosing	FAS subjects with off state at baseline	Hours	MEAN
PRIMARY	Skin Irritation Score of the Application Site	Up to 55 weeks after dosing	SS	participants	NUMBER

Source ClinicalTrials.gov

Results by group25

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

Outcome	Group	Category	Value	Spread	Units
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	Any AEs	126		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	Treatment-Related AEs	112		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	SAEs including death	17		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	Severe AEs	12		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	Discontinuation due to AEs	26		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	Severe laboratory abnormality	10		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	≥30 mmHg decrease*	6		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	Treatment-related AE of orthostatic hypotension	6		participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.	SPM 962	QTcB ≥500 ms	1		participants
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score	SPM 962	Week 12	-9.6	Standard Deviation 8.1	Scores on a scale

1 to 10 of 25Source ClinicalTrials.gov

See all 25 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	130
Overall Study	COMPLETED	SPM 962	93
Overall Study	NOT COMPLETED	SPM 962	37

Source ClinicalTrials.gov

Adverse events56

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	Anaemia	Blood and lymphatic system disorders	SPM 962	5	130	5
other	Nausea	Gastrointestinal disorders	SPM 962	17	130	24
other	Constipation	Gastrointestinal disorders	SPM 962	13	130	13
other	Vomiting	Gastrointestinal disorders	SPM 962	11	130	13
other	Diarrhoea	Gastrointestinal disorders	SPM 962	6	130	6
other	Toothache	Gastrointestinal disorders	SPM 962	4	130	5
other	Application Site Reaction	General disorders	SPM 962	67	130	69
other	Oedema Peripheral	General disorders	SPM 962	8	130	8
other	Application Site Erythema	General disorders	SPM 962	4	130	5
other	Feeling Abnormal	General disorders	SPM 962	4	130	5

1 to 10 of 56Source ClinicalTrials.gov

See all 56 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	119	130
Total, serious adverse events	SPM 962	17	130

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.

For software

Read this trial from software.

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

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