Trial · NCT01634243

A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients

NCT01634243, 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 Dose-ranging Study for SPM 962 in Parkinson's Disease Patients. Trials, record NCT01634243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01634243

On this page

Trial

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

Title: A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients
NCT number: NCT01634243
Status: Completed
Phases: Phase 2
Enrollment: 64 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Parkinson's Disease
Interventions: SPM 962
First posted: 2012-07-06
Last updated: 2014-03-19
Results first posted: 2014-03-19

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Maintenance Dose of the SPM962	Up to 12 weeks after dosing	The maintenance dose of the SPM 962 was examined based on the safety and efficacy.
Secondary	Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	Up to 12 weeks after dosing	Incidence and severity of adverse events, vital signs, and laboratory parameters following the initiation of study treatment.
Secondary	Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy	baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum at 12 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 2 assesses 13 items and 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 for Advanced Parkinson's Disease With Concomitant L-dopa Therapy	baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing. UPDRS sub-scale 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 for Early Parkinson's Disease Without Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score at 12 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	UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing. UPDRS sub-scale 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 (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.	Baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 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	UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.	Baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 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	UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 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	Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and Part 3 sum score at 12 weeks after dosing. UPDRS sub-scale Part 2 assesses 13 items and 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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maintenance Dose of the SPM962	Up to 12 weeks after dosing	Subjects in the safety analysis set who entered the maintenance period	participants	NUMBER
SECONDARY	Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	Up to 12 weeks after dosing	Safety analysis set	participants	NUMBER
SECONDARY	Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy	baseline, 12 weeks after dosing	Efficacy analysis set, last observation carried forward (LOCF)	Scores on a scale	MEAN
SECONDARY	UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy	baseline, 12 weeks after dosing	Efficacy analysis set, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Efficacy analysis set, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Efficacy analysis set, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.	Baseline, 12 weeks after dosing	Efficacy analysis set, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.	Baseline, 12 weeks after dosing	Efficacy analysis set, LOCF	Scores on a scale	MEAN
SECONDARY	UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Efficacy analysis set, LOCF	Scores on a scale	MEAN
SECONDARY	Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy	Baseline, 12 weeks after dosing	Efficacy analysis set, LOCF	Scores on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group43

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

Outcome	Group	Category	Value	Units
Maintenance Dose of the SPM962	Early-stage Parkinson's Disease	4.5 mg	0	participants
Maintenance Dose of the SPM962	Advanced Parkinson's Disease	4.5 mg	0	participants
Maintenance Dose of the SPM962	Early-stage Parkinson's Disease	9.0 mg	0	participants
Maintenance Dose of the SPM962	Advanced Parkinson's Disease	9.0 mg	1	participants
Maintenance Dose of the SPM962	Early-stage Parkinson's Disease	13.5 mg	0	participants
Maintenance Dose of the SPM962	Advanced Parkinson's Disease	13.5 mg	5	participants
Maintenance Dose of the SPM962	Early-stage Parkinson's Disease	18.0 mg	3	participants
Maintenance Dose of the SPM962	Advanced Parkinson's Disease	18.0 mg	5	participants
Maintenance Dose of the SPM962	Early-stage Parkinson's Disease	22.5 mg	2	participants
Maintenance Dose of the SPM962	Advanced Parkinson's Disease	22.5 mg	9	participants

1 to 10 of 43Source ClinicalTrials.gov

See all 43 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Early-stage Parkinson's Disease	21
Overall Study	STARTED	Advanced Parkinson's Disease	43
Overall Study	COMPLETED	Early-stage Parkinson's Disease	15
Overall Study	COMPLETED	Advanced Parkinson's Disease	38
Overall Study	NOT COMPLETED	Early-stage Parkinson's Disease	6
Overall Study	NOT COMPLETED	Advanced Parkinson's Disease	5

Source ClinicalTrials.gov

Adverse events52

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	Early-stage Parkinson's Disease	8	21	9
other	Nausea	Gastrointestinal disorders	Advanced Parkinson's Disease	9	43	10
other	Vomiting	Gastrointestinal disorders	Early-stage Parkinson's Disease	4	21	4
other	Vomiting	Gastrointestinal disorders	Advanced Parkinson's Disease	5	43	8
other	Constipation	Gastrointestinal disorders	Early-stage Parkinson's Disease	3	21	3
other	Constipation	Gastrointestinal disorders	Advanced Parkinson's Disease	4	43	4
other	Stomatitis	Gastrointestinal disorders	Early-stage Parkinson's Disease	2	21	2
other	Stomatitis	Gastrointestinal disorders	Advanced Parkinson's Disease	0	43	0
other	Administration Site Reaction	General disorders	Early-stage Parkinson's Disease	16	21	16
other	Administration Site Reaction	General disorders	Advanced Parkinson's Disease	20	43	20

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Early-stage Parkinson's Disease
Total, all-cause mortality	Advanced Parkinson's Disease
Total, other adverse events	Early-stage Parkinson's Disease	20	21
Total, other adverse events	Advanced Parkinson's Disease	41	43
Total, serious adverse events	Early-stage Parkinson's Disease	1	21
Total, serious adverse events	Advanced Parkinson's Disease	3	43

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Early-stage Parkinson's Disease vs Advanced Parkinson's Disease: serious adverse events

Source Trial comparisons

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/NCT01634243

GET https://conductscience.org/api/trials/v1/NCT01634243/results?page=2

API reference For AI assistants