Trial · NCT02542696
Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
NCT02542696, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2023-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease. Trials, record NCT02542696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02542696
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
- NCT number
- NCT02542696
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 496 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Parkinson Disease
- Interventions
- APL-130277
- First posted
- 2015-09-07
- Last updated
- 2023-11-22
- Other registries' IDs
- eudract:2016-000637-43
- Results first posted
- 2023-11-22
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase | up to approximately 3 years | Number of Participants (%) with Adverse Events in the LTS Phase |
| Secondary | The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 24 Visit (LTS V4) of the LTS Phase Based on the Home Dosing Diary Entries. | Week 24 | The percentage of instances where a full "ON" response was achieved |
| Secondary | The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 36 Visit (LTS V5) of the LTS Phase Based on the Home Dosing Diary Entries. | Week 36 | |
| Secondary | The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 48 Visit (LTS V6) of the LTS Phase Based on the Home Dosing Diary Entries. | Week 48 | |
| Secondary | Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24 | |
| Secondary | Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 36 Visit (LTS V5) of the LTS Phase. | Week 36 | |
| Secondary | Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 48 Visit (LTS V6) of the LTS Phase. | Week 48 | |
| Secondary | Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24, 15 mins after dosing | The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome). |
| Secondary | Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24, 30 mins after dosing | The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome). |
| Secondary | Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24, 60 mins after dosing | The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase | up to approximately 3 years | Based on Long Term Safety Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 24 Visit (LTS V4) of the LTS Phase Based on the Home Dosing Diary Entries. | Week 24 | Based on the number of subjects who provided data at the specified timepoint in the analysis population | percentage of instances | MEAN |
| SECONDARY | The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 36 Visit (LTS V5) of the LTS Phase Based on the Home Dosing Diary Entries. | Week 36 | Based on the number of subjects who provided data at the specified timepoint in the analysis population | percentage of instances | MEAN |
| SECONDARY | The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 48 Visit (LTS V6) of the LTS Phase Based on the Home Dosing Diary Entries. | Week 48 | Based on the number of subjects who provided data at the specified timepoint in the analysis population | percentage of instances | MEAN |
| SECONDARY | Percentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24 | Based on the number of subjects who provided data at the specified timepoint in the analysis population | percent of participants | NUMBER |
| SECONDARY | Percentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 36 Visit (LTS V5) of the LTS Phase. | Week 36 | Based on the number of subjects who provided data at the specified timepoint in the analysis population | percent of participants | NUMBER |
| SECONDARY | Percentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 48 Visit (LTS V6) of the LTS Phase. | Week 48 | Based on the number of subjects who provided data at the specified timepoint in the analysis population | percent of participants | NUMBER |
| SECONDARY | Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24, 15 mins after dosing | Based on the number of subjects who provided data at the specified timepoint in the analysis population | Units on a scale | MEAN |
| SECONDARY | Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24, 30 mins after dosing | Based on the number of subjects who provided data at the specified timepoint in the analysis population | Units on a scale | MEAN |
| SECONDARY | Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | Week 24, 60 mins after dosing | Based on the number of subjects who provided data at the specified timepoint in the analysis population | Units on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase | APL-130277 | 365 | Participants | ||
The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 24 Visit (LTS V4) of the LTS Phase Based on the Home Dosing Diary Entries. | APL-130277 | 80.7 | Standard Deviation 32.55 | percentage of instances | |
The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 36 Visit (LTS V5) of the LTS Phase Based on the Home Dosing Diary Entries. | APL-130277 | 87.3 | Standard Deviation 28.70 | percentage of instances | |
The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 48 Visit (LTS V6) of the LTS Phase Based on the Home Dosing Diary Entries. | APL-130277 | 84.1 | Standard Deviation 30.74 | percentage of instances | |
| Percentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 24 Visit (LTS V4) of the LTS Phase. | APL-130277 | 77.2 | percent of participants | ||
| Percentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 36 Visit (LTS V5) of the LTS Phase. | APL-130277 | 83.9 | percent of participants | ||
| Percentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 48 Visit (LTS V6) of the LTS Phase. | APL-130277 | 84.4 | percent of participants | ||
| Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | APL-103277 | -14.2 | Standard Deviation 11.91 | Units on a scale | |
| Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | APL-103277 | -22.1 | Standard Deviation 13.04 | Units on a scale | |
| Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. | APL-103277 | -21.0 | Standard Deviation 13.34 | Units on a scale |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | APL-130277 | 496 | |
| Overall Study | Titration Full Analysis Population | APL-130277 | 449 | |
| Overall Study | LTS Phase Full Analysis Population | APL-130277 | 426 | |
| Overall Study | COMPLETED | APL-130277 | 120 | |
| Overall Study | NOT COMPLETED | APL-130277 | 376 |
Source ClinicalTrials.gov
Adverse events119
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 | Lip swelling | Gastrointestinal disorders | APL-130277 | 27 | 496 | 36 |
| other | Mouth ulceration | Gastrointestinal disorders | APL-130277 | 28 | 496 | 37 |
| other | Nausea | Gastrointestinal disorders | APL-130277 | 136 | 496 | 197 |
| other | Oral mucosal erythema | Gastrointestinal disorders | APL-130277 | 43 | 496 | 60 |
| other | Stomatitis | Gastrointestinal disorders | APL-130277 | 25 | 496 | 39 |
| other | Fatigue | General disorders | APL-130277 | 35 | 496 | 48 |
| other | Fall | Injury, poisoning and procedural complications | APL-130277 | 44 | 496 | 63 |
| other | Dizziness | Nervous system disorders | APL-130277 | 52 | 496 | 70 |
| other | Dyskinesia | Nervous system disorders | APL-130277 | 34 | 496 | 47 |
| other | Headache | Nervous system disorders | APL-130277 | 31 | 496 | 43 |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APL-130277 | 8 | 496 |
| Total, other adverse events | APL-130277 | 319 | 496 |
| Total, serious adverse events | APL-130277 | 64 | 496 |
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.
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/NCT02542696
GET https://conductscience.org/api/trials/v1/NCT02542696/events?page=2