Trial · NCT01628848
A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
NCT01628848, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients. Trials, record NCT01628848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01628848
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
- NCT number
- NCT01628848
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 174 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Parkinson's Disease
- Interventions
- SPM 962, Placebo
- First posted
- 2012-06-27
- Last updated
- 2014-03-19
- Results first posted
- 2014-03-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score | baseline, 12 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 3 sum score 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 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 Score of on State and Off State) | baseline, 12 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 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 | Off Time | baseline, 12 weeks after dosing | Mean change (LOCF) from baseline in off time at 12 weeks after dosing. |
| Secondary | Effective Rate in UPDRS Part 3 Sum Score | Baseline, 12 weeks after dosing | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing. |
| Secondary | UPDRS Part 1 Sum Score | Baseline, 12 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 weeks after dosing. 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 | Effective Rate in Off Time | Baseline, 12 weeks after dosing. | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing. |
| Secondary | UPDRS Part 2 Sum Score (on State) | 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) | 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 4 Sum Score | Baseline, 12 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 4 sum score at 12 weeks after dosing. 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 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score | 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 UPDRS 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 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Scale (UPDRS) Part 3 Sum Score | baseline, 12 weeks after dosing | Full analysis set (FAS), last observation carried forward (LOCF) | Scores on a scale | MEAN |
| SECONDARY | UPDRS Part 2 Sum Score (Average Score of on State and Off State) | baseline, 12 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | Off Time | baseline, 12 weeks after dosing | FAS subjects with measurable off time data at baseline, LOCF | Hours | MEAN |
| SECONDARY | Effective Rate in UPDRS Part 3 Sum Score | Baseline, 12 weeks after dosing | FAS, LOCF | Percentage of participants | NUMBER |
| SECONDARY | UPDRS Part 1 Sum Score | Baseline, 12 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | Effective Rate in Off Time | Baseline, 12 weeks after dosing. | FAS subjects with measurable off time data at baseline, LOCF | Percentage of participants | NUMBER |
| SECONDARY | UPDRS Part 2 Sum Score (on State) | Baseline, 12 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | UPDRS Part 2 Sum Score (Off State) | Baseline, 12 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | UPDRS Part 4 Sum Score | Baseline, 12 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
| SECONDARY | Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score | Baseline, 12 weeks after dosing | FAS, LOCF | Scores on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group32
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 Scale (UPDRS) Part 3 Sum Score | SPM 962 | -10.1 | Standard Deviation 9.0 | Scores on a scale | |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score | Placebo | -4.4 | Standard Deviation 7.4 | Scores on a scale | |
| UPDRS Part 2 Sum Score (Average Score of on State and Off State) | SPM 962 | -3.8 | Standard Deviation 3.6 | Scores on a scale | |
| UPDRS Part 2 Sum Score (Average Score of on State and Off State) | Placebo | -1.6 | Standard Deviation 2.6 | Scores on a scale | |
| Off Time | SPM 962 | -2.1 | Standard Deviation 3.1 | Hours | |
| Off Time | Placebo | -0.7 | Standard Deviation 2.8 | Hours | |
| Effective Rate in UPDRS Part 3 Sum Score | SPM 962 | Subjects with ≥20% decrease | 73.3 | 95% Confidence Interval 63.9 to 82.6 | Percentage of participants |
| Effective Rate in UPDRS Part 3 Sum Score | Placebo | Subjects with ≥20% decrease | 43.0 | 95% Confidence Interval 32.6 to 53.5 | Percentage of participants |
| Effective Rate in UPDRS Part 3 Sum Score | SPM 962 | Subjects with ≥30% decrease | 64.0 | 95% Confidence Interval 53.8 to 74.1 | Percentage of participants |
| Effective Rate in UPDRS Part 3 Sum Score | Placebo | Subjects with ≥30% decrease | 29.1 | 95% Confidence Interval 19.5 to 38.7 | Percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPM 962 | 87 | |
| Overall Study | STARTED | Placebo | 87 | |
| Overall Study | COMPLETED | SPM 962 | 75 | |
| Overall Study | COMPLETED | Placebo | 73 | |
| Overall Study | NOT COMPLETED | SPM 962 | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events76
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 | 3 | 87 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 87 | 1 |
| other | Nausea | Gastrointestinal disorders | SPM 962 | 17 | 87 | 17 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 87 | 8 |
| other | Constipation | Gastrointestinal disorders | SPM 962 | 9 | 87 | 9 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 87 | 1 |
| other | Vomiting | Gastrointestinal disorders | SPM 962 | 9 | 87 | 10 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 87 | 1 |
| other | Gastric Ulcer | Gastrointestinal disorders | SPM 962 | 4 | 87 | 4 |
| other | Gastric Ulcer | Gastrointestinal disorders | Placebo | 0 | 87 | 0 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPM 962 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | SPM 962 | 80 | 87 |
| Total, other adverse events | Placebo | 59 | 87 |
| Total, serious adverse events | SPM 962 | 3 | 87 |
| Total, serious adverse events | Placebo | 3 | 87 |
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 |
|---|
| SPM 962 vs Placebo: 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.
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/NCT01628848
GET https://conductscience.org/api/trials/v1/NCT01628848/results?page=2