Trial · NCT02228590
A Study to Examine APL-130277 in Patients With Parkinson's Disease
NCT02228590, Phase 2, Completed, Sumitomo Pharma America, Inc.; results first posted 2020-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Examine APL-130277 in Patients With Parkinson's Disease. Trials, record NCT02228590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02228590
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Examine APL-130277 in Patients With Parkinson's Disease
- NCT number
- NCT02228590
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Parkinson's Disease
- Interventions
- APL-130277
- First posted
- 2014-08-29
- Last updated
- 2020-07-30
- Results first posted
- 2020-07-30
- Limitations and caveats
Due to the 90-minute sampling estimate λz values or calculate AUCinf, AUCext, or half-life as stated in the protocol was not possible.No PK parameters were calculated for subjects with fewer than 4 quantifiable concentrations following BLQ imputation
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | Clinical confirmation of an 'OFF' state was assessed prior to dosing and confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The first full 'ON' dose was defined as the earliest dose in which a patient achieved a full 'ON' state as assessed by the Investigator. The percentage of patients who achieved their first full 'ON' is presented for each timepoint, regardless of the dose received, and for the study overall (i.e. all post-dose timepoints). |
| Primary | Time to 'ON' State From Time of Dosing of APL-130277 | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The time to the full 'ON' state from the time of dosing in minutes was calculated from timings noted by the Investigator and recorded in the electronic case report form (eCRF). The mean time taken for a patient to reach their first full 'ON' state following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. |
| Primary | Duration of 'ON' Response From Time of Dosing of APL-130277 | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The duration of the 'ON' response was defined as the length of time in which a patient was confirmed 'ON' within a dose, and was calculated from the time noted by the Investigator and recorded in the eCRF. The mean duration of the first full 'ON' response following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. |
| Primary | Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. For the overall study, the percentage of patients who completed the trial, and who experienced an 'ON' episode is presented. |
| Primary | Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | The mean Cmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay, with a lower limit of quantification of 0.020 nanograms per millilitre (ng/mL). |
| Primary | PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | The median Tmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. |
| Primary | PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | The mean Tlast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. |
| Primary | PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | The mean AUC0-90 values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. |
| Primary | PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | The mean AUClast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. The AUClast was calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method). |
| Secondary | Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | The Motor Function section (Section III) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The percent change in the MDS-UPDRS Section III score from pre-dose to the first full ON dose or last dose for non-responders is presented. A negative change from baseline indicates an improvement. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | The modified Intent-to-Treat (mITT) Population consisted of all patients who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Time to 'ON' State From Time of Dosing of APL-130277 | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | The mITT Population consisted of all patients who received at least 1 dose of study medication, and data is presented for patients who turned 'ON'. | minutes | MEAN |
| PRIMARY | Duration of 'ON' Response From Time of Dosing of APL-130277 | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | The mITT Population consisted of all patients who received at least 1 dose of study medication, and data is presented for patients who turned 'ON'. | minutes | MEAN |
| PRIMARY | Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | The mITT Population consisted of all patients who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | ng/mL | MEAN |
| PRIMARY | PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | minutes | MEDIAN |
| PRIMARY | PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | minutes | MEAN |
| PRIMARY | PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | min*ng/mL | MEAN |
| PRIMARY | PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast) | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | min*ng/mL | MEAN |
| SECONDARY | Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. | The mITT Population consisted of all patients who received at least 1 dose of study medication. | percent of change | MEAN |
Source ClinicalTrials.gov
Results by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | APL-130277 | Overall | 78.9 | percentage of participants | |
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | APL-130277 | 15 minutes post-dose | 31.6 | percentage of participants | |
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | APL-130277 | 30 minutes post-dose | 78.9 | percentage of participants | |
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | APL-130277 | 45 minutes post-dose | 68.4 | percentage of participants | |
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | APL-130277 | 60 minutes post-dose | 68.4 | percentage of participants | |
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | APL-130277 | 90 minutes post-dose | 47.4 | percentage of participants | |
| Time to 'ON' State From Time of Dosing of APL-130277 | APL-130277 | 24.0 | Standard Deviation 7.61 | minutes | |
| Duration of 'ON' Response From Time of Dosing of APL-130277 | APL-130277 | 50.0 | Standard Deviation 19.36 | minutes | |
| Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode | APL-130277 | 78.9 | percentage of participants | ||
| Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax) | APL-130277 | 10 mg APL-130277 Dose 1 Day 1 | 2.01 | Standard Deviation 0.914 | ng/mL |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | APL-130277 | 20 | |
| Overall Study | COMPLETED | APL-130277 | 19 | |
| Overall Study | NOT COMPLETED | APL-130277 | 1 |
Source ClinicalTrials.gov
Adverse events24
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 | APL-130277 | 4 | 19 | 8 |
| other | vomiting | Gastrointestinal disorders | APL-130277 | 1 | 19 | 1 |
| other | chest discomfort | General disorders | APL-130277 | 1 | 19 | 1 |
| other | chest pain | General disorders | APL-130277 | 1 | 19 | 1 |
| other | fatigue | General disorders | APL-130277 | 1 | 19 | 1 |
| other | muscle spasms | Musculoskeletal and connective tissue disorders | APL-130277 | 1 | 19 | 1 |
| other | muscuar weakness | Musculoskeletal and connective tissue disorders | APL-130277 | 1 | 19 | 1 |
| other | musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | APL-130277 | 1 | 19 | 1 |
| other | neck pain | Musculoskeletal and connective tissue disorders | APL-130277 | 1 | 19 | 1 |
| other | balance disorder | Nervous system disorders | APL-130277 | 1 | 19 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APL-130277 | 0 | 19 |
| Total, other adverse events | APL-130277 | 13 | 19 |
| Total, serious adverse events | APL-130277 | 1 | 19 |
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/NCT02228590
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