Trial · NCT02469090
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
NCT02469090, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2020-07-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease. Trials, record NCT02469090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02469090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
- NCT number
- NCT02469090
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 141 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Parkinson Disease, Off Episodes
- Interventions
- APL-130277, Placebo
- First posted
- 2015-06-11
- Last updated
- 2020-07-30
- Results first posted
- 2020-07-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Pre-Dose to 30 Minutes Post-Dose in The Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score at Maintenance Visit 4 (MV4) - Week 12 | At t=0 (just prior to dosing) and t=30 minutes at MV4 (Week 12 of the Maintenance Treatment Phase). | The Motor Function section (Part III) of the MDS-UPDRS was administered by the Investigator, and 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 least square mean change in the MDS-UPDRS Part III score from pre-dose to 30 minutes post-dose at MV4 is presented. A negative change from pre-dose indicates an improvement. |
| Secondary | Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes at MV4 - Week 12: Predicted Response Rate | At t=30 minutes at MV4 (Week 12 of the Maintenance Treatment Phase). | A full 'ON' response was defined as a period of time where in the judgment of the patient the medication was providing full benefit with regard to mobility, stiffness, slowness and other PD features comparable to or better than that obtained with their standard dose of oral L-dopa and other anti-parkinsonian medications prior to beginning the study. Patients were asked if they attained a full 'ON' state anytime within 30 minutes of dosing. The predicted response rates are presented and were estimated using a generalized linear mixed model. |
| Secondary | Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes That Had a Duration of Effect of at Least 30 Minutes at MV4 - Week 12: Predicted Response Rate | At MV4 (Week 12 of the Maintenance Treatment Phase). | A full 'ON' response was defined as a period of time where in the judgment of the patient the medication was providing full benefit with regard to mobility, stiffness, slowness and other PD features comparable to or better than that obtained with their standard dose of oral L-dopa and other anti-parkinsonian medications prior to beginning the study. The percentage of patients who attained a full 'ON' within 30 minutes of dosing, and whose duration from time when study medication began to have an effect lasted for at least 30 minutes were evaluated. The predicted response rates are presented and were estimated using a generalized linear mixed model. |
| Secondary | Patient Global Impression of Improvement (PGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | At MV4 (Week 12 of the Maintenance Treatment Phase). | During the PGI-I assessment the patient was asked to answer the question "Since starting study medication, how has your illness changed?" with 1 of the following responses: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse and 7 = very much worse. The percentage of patients who improved at MV4 (gave responses 1 - 3) are presented. |
| Secondary | Clinician Global Impression of Improvement (CGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | At MV4 (Week 12 of the Maintenance Treatment Phase). | During the CGI-I assessment the clinician using the question "Compared to his/her condition on baseline, how much has he/she changed?" provided 1 of the following responses: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse and 7 = very much worse. The percentage of patients who improved at MV4 (responses 1 - 3) are presented. |
| Secondary | Mean Change From Screening Visit to MV4 (Week 12) in MDS-UPDRS Part II: Motor Aspects of Experience of Daily Living | At Screening Visit and at MV4 (Week 12 of the Maintenance Treatment Phase). | Part II of the MDS-UPDRS assessed motor experiences of daily living and was self-administered by the patient. The MDS-UPDRS Part II score was calculated as the sum of the individual items of the MDS-UPDRS Part II questionnaire (items 2.1 - 2.13), and was based on 13-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 52, with a lower score indicating better motor function for daily living and a higher score indicating more severe motor symptoms. The mean change in the MDS-UPDRS Part II score from the screening visit to Week 12 of the Maintenance Treatment Phase is presented. A negative change indicates an improvement. |
| Secondary | Mean Percentage of Instances Where a Full 'ON' Response Was Achieved at 30 Minutes Post-dose on the Home Dosing Diary Entries During the 2 Days Prior to MV4 - Week 12 | 2 days prior to MV4 (Week 12 of the Maintenance Treatment Phase). | Patients self-administered their doses of randomized study medication in order to treat up to 5 'OFF' episodes per day and recorded the time of self-administration and the 'ON'/'OFF' status at 30 minutes post-dose in a home dosing diary. A full 'ON' response was defined as a period of time where in the judgment of the patient the medication was providing full benefit with regard to mobility, stiffness, slowness and other PD features comparable to or better than that obtained with their standard dose of oral L-dopa and other anti-parkinsonian medications prior to beginning the study. The percentage of instances in which a full 'ON' response was achieved at 30 minutes out of all recorded episodes was calculated and is presented, and the mean percentage is presented. |
| Secondary | Mean Change From Screening Visit to MV4 in the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Summary Index Score | At Screening Visit and at MV4 (Week 12 of the Maintenance Treatment Phase). | The PDQ-39 was self-administered by the patient during screening and at each MV. The PDQ-39 assessed the impact of PD on the quality of life in the preceding month using 39-items, each anchored with 5 responses: Never, Occasionally, Sometimes, Often and Always. Items were grouped into 8 scales (Mobility, Activities of daily living, Emotional well-being, Stigma, Social support, Cognitions, Communication and Bodily discomfort) that were scored by expressing summed item scores as a percentage score ranging between 0 and 100. The PDQ-39 summary index score was derived by the sum of the 8 PDQ-39 scale scores divided by 8, yielding a score between 0 and 100. 0 indicates perfect health and 100 indicates worse health as assessed by the measure. A negative change indicates an improvement. |
| Secondary | Mean Change From Pre-Dose to 15 Minutes Post-Dose in the MDS-UPDRS Part III Score at MV4 - Week 12 | At t=0 (just prior to dosing) and t=15 minutes at MV4 (Week 12 of the Maintenance Treatment Phase). | The Motor Function section (Part III) of the MDS-UPDRS was administered by the Investigator, and 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 mean change in the MDS-UPDRS Part III score from pre-dose to 15 minutes post-dose at MV4 is presented. A negative change indicates an improvement. |
| Secondary | Time From Dosing to When Study Medication Provided an Effect at MV4 - Week 12 | At MV4 (Week 12 of the Maintenance Treatment Phase). | The time to effect at MV4 was described using the Kaplan-Meier method, including an estimate of the median time to effect and corresponding 95% confidence interval. |
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 | Mean Change From Pre-Dose to 30 Minutes Post-Dose in The Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score at Maintenance Visit 4 (MV4) - Week 12 | At t=0 (just prior to dosing) and t=30 minutes at MV4 (Week 12 of the Maintenance Treatment Phase). | The modified Intention-To-Treat (mITT) Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes at MV4 - Week 12: Predicted Response Rate | At t=30 minutes at MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | number of participants | NUMBER |
| SECONDARY | Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes That Had a Duration of Effect of at Least 30 Minutes at MV4 - Week 12: Predicted Response Rate | At MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | number of participants | NUMBER |
| SECONDARY | Patient Global Impression of Improvement (PGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | At MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | percentage of participants | NUMBER |
| SECONDARY | Clinician Global Impression of Improvement (CGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | At MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Screening Visit to MV4 (Week 12) in MDS-UPDRS Part II: Motor Aspects of Experience of Daily Living | At Screening Visit and at MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percentage of Instances Where a Full 'ON' Response Was Achieved at 30 Minutes Post-dose on the Home Dosing Diary Entries During the 2 Days Prior to MV4 - Week 12 | 2 days prior to MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | percentage of instnces | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Screening Visit to MV4 in the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Summary Index Score | At Screening Visit and at MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Pre-Dose to 15 Minutes Post-Dose in the MDS-UPDRS Part III Score at MV4 - Week 12 | At t=0 (just prior to dosing) and t=15 minutes at MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time From Dosing to When Study Medication Provided an Effect at MV4 - Week 12 | At MV4 (Week 12 of the Maintenance Treatment Phase). | The mITT Population consisted of all patients who were randomized and received at least 1 post-randomization dose of study medication (APL-130277 or placebo). Patients were grouped according to the randomized treatment group. Only patients with data available for analysis at the time point are presented. | Minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Mean Change From Pre-Dose to 30 Minutes Post-Dose in The Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score at Maintenance Visit 4 (MV4) - Week 12 | Placebo (Maintenance) | -3.5 | Standard Error 1.29 | Units on a scale | |
Mean Change From Pre-Dose to 30 Minutes Post-Dose in The Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score at Maintenance Visit 4 (MV4) - Week 12 | APL-130277 (Maintenance) | -11.1 | Standard Error 1.46 | Units on a scale | |
| Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes at MV4 - Week 12: Predicted Response Rate | Placebo (Maintenance) | 16 | number of participants | ||
| Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes at MV4 - Week 12: Predicted Response Rate | APL-130277 (Maintenance) | 35 | number of participants | ||
| Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes That Had a Duration of Effect of at Least 30 Minutes at MV4 - Week 12: Predicted Response Rate | Placebo (Maintenance) | 14 | number of participants | ||
| Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes That Had a Duration of Effect of at Least 30 Minutes at MV4 - Week 12: Predicted Response Rate | APL-130277 (Maintenance) | 31 | number of participants | ||
| Patient Global Impression of Improvement (PGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | Placebo (Maintenance) | 20.0 | percentage of participants | ||
| Patient Global Impression of Improvement (PGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | APL-130277 (Maintenance) | 37.0 | percentage of participants | ||
| Clinician Global Impression of Improvement (CGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | Placebo (Maintenance) | 20.0 | percentage of participants | ||
| Clinician Global Impression of Improvement (CGI-I): Percentage of Patients Who Improved at MV4 - Week 12 | APL-130277 (Maintenance) | 40.7 | percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Dose Titration Phase | STARTED | APL-130277 (Titration) | 141 | |
| Period 1: Dose Titration Phase | STARTED | Placebo (Maintnance) | 0 | |
| Period 1: Dose Titration Phase | STARTED | APL-130277 (Maintenance) | 0 | |
| Period 1: Dose Titration Phase | COMPLETED | APL-130277 (Titration) | 109 | |
| Period 1: Dose Titration Phase | COMPLETED | Placebo (Maintnance) | 0 | |
| Period 1: Dose Titration Phase | COMPLETED | APL-130277 (Maintenance) | 0 | |
| Period 1: Dose Titration Phase | NOT COMPLETED | APL-130277 (Titration) | 32 | |
| Period 1: Dose Titration Phase | NOT COMPLETED | Placebo (Maintnance) | 0 | |
| Period 1: Dose Titration Phase | NOT COMPLETED | APL-130277 (Maintenance) | 0 | |
| Period 2: Maintenance Treatment Phase | STARTED | APL-130277 (Titration) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events99
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 (Titration) | 29 | 141 | 40 |
| other | Nausea | Gastrointestinal disorders | Placebo (Maintenance) | 2 | 55 | 2 |
| other | Nausea | Gastrointestinal disorders | APL-130277 (Maintenance) | 15 | 54 | 18 |
| other | Oral mucosalerythema | Gastrointestinal disorders | APL-130277 (Titration) | 6 | 141 | 13 |
| other | Oral mucosalerythema | Gastrointestinal disorders | Placebo (Maintenance) | 2 | 55 | 2 |
| other | Oral mucosalerythema | Gastrointestinal disorders | APL-130277 (Maintenance) | 4 | 54 | 4 |
| other | Vomiting | Gastrointestinal disorders | APL-130277 (Titration) | 6 | 141 | 6 |
| other | Vomiting | Gastrointestinal disorders | Placebo (Maintenance) | 0 | 55 | 0 |
| other | Vomiting | Gastrointestinal disorders | APL-130277 (Maintenance) | 4 | 54 | 5 |
| other | Dry mouth | Gastrointestinal disorders | APL-130277 (Titration) | 2 | 141 | 4 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APL-130277 (Titration) | 0 | 141 |
| Total, all-cause mortality | Placebo (Maintenance) | 0 | 55 |
| Total, all-cause mortality | APL-130277 (Maintenance) | 1 | 54 |
| Total, other adverse events | APL-130277 (Titration) | 60 | 141 |
| Total, other adverse events | Placebo (Maintenance) | 12 | 55 |
| Total, other adverse events | APL-130277 (Maintenance) | 39 | 54 |
| Total, serious adverse events | APL-130277 (Titration) | 1 | 141 |
| Total, serious adverse events | Placebo (Maintenance) | 1 | 55 |
| Total, serious adverse events | APL-130277 (Maintenance) | 2 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31818699 | DERIVED |
Source PubMed
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/NCT02469090
GET https://conductscience.org/api/trials/v1/NCT02469090/events?page=2