Trial · NCT01628965

A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients

NCT01628965, Phase 2, 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 Phase II/III of SPM 962 in Early Parkinson's Disease Patients. Trials, record NCT01628965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01628965

On this page

Trial

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

Title: A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients
NCT number: NCT01628965
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 143 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Parkinson's Disease
Interventions: SPM 962
First posted: 2012-06-27
Last updated: 2014-03-19
Results first posted: 2014-03-19

Source ClinicalTrials.gov

Registered outcomes3

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 up to 54 weeks 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	Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score	Baseline, Up to 54 weeks after dosing	Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS 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.

Source ClinicalTrials.gov

Outcomes3

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	Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and 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
PRIMARY	Skin Irritation Score of the Application Site	Up to 55 weeks after dosing	SS	participants	NUMBER

Source ClinicalTrials.gov

Results by group21

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, Vital Signs, and Laboratory Parameters	SPM 962	Any AEs	140	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	Treatment-related AEs	122	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	SAEs	18	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	Severe AEs	9	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	Discontinuation due to AEs	30	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	Severe laboratory abnormality	14	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	≥30 mmHg decrease*	1	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	Treatment-related AE of orthostatic hypotension	2	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	QTcB ≥500 ms	1	participants
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters	SPM 962	Weight decrease of 5% or more	53	participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 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	143
Overall Study	COMPLETED	SPM 962	94
Overall Study	NOT COMPLETED	SPM 962	49

Source ClinicalTrials.gov

Adverse events41

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	Vertigo	Ear and labyrinth disorders	SPM 962	5	143	6
other	Nausea	Gastrointestinal disorders	SPM 962	47	143	57
other	Vomiting	Gastrointestinal disorders	SPM 962	22	143	44
other	Constipation	Gastrointestinal disorders	SPM 962	21	143	21
other	Application Site Reaction	General disorders	SPM 962	96	143	100
other	Oedema Peripheral	General disorders	SPM 962	7	143	8
other	Nasopharyngitis	Infections and infestations	SPM 962	26	143	29
other	Cystitis	Infections and infestations	SPM 962	5	143	5
other	Contusion	Injury, poisoning and procedural complications	SPM 962	7	143	8
other	Blood Creatine Phosphokinase Increased	Investigations	SPM 962	6	143	7

1 to 10 of 41Source ClinicalTrials.gov

See all 41 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	138	143
Total, serious adverse events	SPM 962	24	143

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.

GET https://conductscience.org/api/trials/v1/NCT01628965

GET https://conductscience.org/api/trials/v1/NCT01628965/results?page=2

API reference For AI assistants