Trial · NCT03391882
A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
NCT03391882, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2022-12-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes). Trials, record NCT03391882. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03391882
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
- NCT number
- NCT03391882
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 113 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Motor OFF Episodes Associated With Parkinson's Disease
- Interventions
- APL-130277, subcutaneous apomorphine
- First posted
- 2018-01-05
- Last updated
- 2022-12-16
- Other registries' IDs
- eudract:2016-003456-70
- Results first posted
- 2022-12-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Pre-dose to 90 Mins. Post-dose in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Score After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | Pre-dose to 90 minutes post-dose at Week 4 of each treatment period (Visit 3 and 6) | The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society. The summary score used in this study for the primary objective and primary efficacy endpoint is Part III motor examination score. Each Part III item has a 0-4 rating, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. 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. 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 | Durability of Effect, Defined as an Investigator Confirmed Full "ON" Within 30 Minutes Post Dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | Within 30 minutes post-dose and at 90 minutes post-dose at Week 4 of each treatment period (Visit 3 and 6) | Investigator will confirm whether subject is "OFF", Full "ON" or Partial "ON" , and note the time the subject changes from "OFF" to Partial "ON" or Full "ON". The Investigator will also record the subject "ON"/"OFF" status (binary variable, Yes / No) prior to performing each MDS-UPDRS Part III assessment. Durability of effect is defined as an Investigator confirmed full "ON" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each PART B crossover period. Response rate = % of subjects that achived full "ON" within the timeframe |
| Secondary | Subject Preference for APL Treatment as Measured by the Subject Treatment Preference Questionnaire (TPQ), Planned After the Subject Had Completed Both APL-130277 and sc Apomorphine Treatment Regimens (Assessed In-clinic at Visit 6 of PART B) | After 8 weeks of treatment (Visit 6) | The TPQ assessment of subject treatment preference was changed from being based on a visual analogue scale or VAS (Q9b)) to a 5-point Likert scale (Q9a). Subject reported preference for APL or SC was based on question Q9a or Q9b combined. For Q9a, responses were dichotomized as follows for statistical analysis: preference for APL (responses of either definitely or somewhat prefer APL) versus no preference for APL (responses of no preference, or somewhat/definitely prefer sc apomorphine). The VAS score was similarly dichotomized as preference for APL (score of \>0 to 50) versus no preference for APL (-50 to 0). If a subject responded to both Q9a and Q9b, then Q9a only was used. |
| Secondary | Subject Confirmed Durability of Effect, Defined as Subject Confirmed Full "ON" Within 30 Minutes Post-dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | Week 4 | Patients will confirm whether he/she is "OFF", Full "ON" or Partial "ON", and the staff will ask the subject to notify the staff when he/she changes from "OFF" to Partial "ON" or Full "ON" (binary variable, Yes / No) . Subject confirmed durability of effect is defined as subject confirmed full "ON" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at V3 and V6 of PART B). Response rate = % subjects that achived full ON within the timeframe |
| Secondary | Patient Global Impression of Change (PGI-C): Subject Improvement of "OFF" Episodes, Defined as Very Much Better, Much Better or a Little Better After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | At Week 4 of each treatment period (Visit 3 and 6, or Early Termination) | The PGI-C is the patient reported outcome counterpart to the Clinical Global Impressions scale, (CGI), which was published in 1976 by the National Institute of Mental Health (US). It consists of one item taken from the CGI and adapted to the patient. The PGI-C is based on a 7-point scale, where a lower score is associated with higher symptom improvement. The scale is: Very much better Much better A little better No change A little worse Much worse Very much worse Subject improvement of "OFF" episodes is defined as very much better, much better or a little better at Week 4 in each PART B crossover period. Response rate= % of subjects who achieved improvement of "OFF" episodes |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Pre-dose to 90 Mins. Post-dose in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Score After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | Pre-dose to 90 minutes post-dose at Week 4 of each treatment period (Visit 3 and 6) | Part B mITT population | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Durability of Effect, Defined as an Investigator Confirmed Full ON Within 30 Minutes Post Dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | Within 30 minutes post-dose and at 90 minutes post-dose at Week 4 of each treatment period (Visit 3 and 6) | Part B mITT population | Percentage of participants | NUMBER |
| SECONDARY | Subject Preference for APL Treatment as Measured by the Subject Treatment Preference Questionnaire (TPQ), Planned After the Subject Had Completed Both APL-130277 and sc Apomorphine Treatment Regimens (Assessed In-clinic at Visit 6 of PART B) | After 8 weeks of treatment (Visit 6) | Part B mITT population | % of participants | NUMBER |
| SECONDARY | Subject Confirmed Durability of Effect, Defined as Subject Confirmed Full ON Within 30 Minutes Post-dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | Week 4 | Part B mITT population | Percentage of participants | NUMBER |
| SECONDARY | Patient Global Impression of Change (PGI-C): Subject Improvement of OFF Episodes, Defined as Very Much Better, Much Better or a Little Better After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | At Week 4 of each treatment period (Visit 3 and 6, or Early Termination) | Part B mITT population | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Change From Pre-dose to 90 Mins. Post-dose in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Score After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | SC (Subcutaneous Apomorphine) | -13.78 | 95% Confidence Interval -16.65 to -10.90 | Units on a scale | |
Change From Pre-dose to 90 Mins. Post-dose in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Score After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | APL (APL-130277) | -13.55 | 95% Confidence Interval -16.39 to -10.70 | Units on a scale | |
Durability of Effect, Defined as an Investigator Confirmed Full ON Within 30 Minutes Post Dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | SC (Subcutaneous Apomorphine) | 18.03 | Percentage of participants | ||
Durability of Effect, Defined as an Investigator Confirmed Full ON Within 30 Minutes Post Dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed by the Blinded-rater In-clinic at Visit 3 and Visit 6 of PART B). | APL (APL-130227) | 17.74 | Percentage of participants | ||
Subject Preference for APL Treatment as Measured by the Subject Treatment Preference Questionnaire (TPQ), Planned After the Subject Had Completed Both APL-130277 and sc Apomorphine Treatment Regimens (Assessed In-clinic at Visit 6 of PART B) | Overall | 72.2 | 95% Confidence Interval 61.9 to 82.6 | % of participants | |
Subject Confirmed Durability of Effect, Defined as Subject Confirmed Full ON Within 30 Minutes Post-dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | SC (Subcutaneous Apomorphine) | 14.75 | Percentage of participants | ||
Subject Confirmed Durability of Effect, Defined as Subject Confirmed Full ON Within 30 Minutes Post-dose and at 90 Minutes Post-dose, After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | APL (APL-130227) | 19.36 | Percentage of participants | ||
Patient Global Impression of Change (PGI-C): Subject Improvement of OFF Episodes, Defined as Very Much Better, Much Better or a Little Better After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | SC (Subcutaneous Apomorphine) | 77.14 | Percentage of participants | ||
Patient Global Impression of Change (PGI-C): Subject Improvement of OFF Episodes, Defined as Very Much Better, Much Better or a Little Better After 4 Weeks of Dosing in Each Crossover Period (Assessed In-clinic at Visit 3 and Visit 6 of PART B). | APL (APL-130277) | 83.10 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Overall | STARTED | APL-SC | 20 | |
| Study Overall | STARTED | SC-APL | 19 | |
| Study Overall | STARTED | APL-SC-APL-SC | 19 | |
| Study Overall | STARTED | APL-SC-SC-APL | 18 | |
| Study Overall | STARTED | SC-APL-APL-SC | 18 | |
| Study Overall | STARTED | SC-APL-SC-APL | 19 | |
| Study Overall | Safety Population | APL-SC | 20 | |
| Study Overall | Safety Population | SC-APL | 18 | |
| Study Overall | Safety Population | APL-SC-APL-SC | 19 | |
| Study Overall | Safety Population | APL-SC-SC-APL | 18 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events52
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 | Part A Dose Titration: APL (APL-130277) | 32 | 102 | 53 |
| other | Nausea | Gastrointestinal disorders | Part A Dose Titration: SC (Subcutaneous Apomorphine) | 22 | 97 | 31 |
| other | Nausea | Gastrointestinal disorders | Part B Treatment: APL (APL-130277) | 10 | 71 | 25 |
| other | Nausea | Gastrointestinal disorders | Part B Treatment: SC (Subcutaneous Apomorphine) | 11 | 70 | 21 |
| other | Fatigue | General disorders | Part A Dose Titration: APL (APL-130277) | 6 | 102 | 6 |
| other | Fatigue | General disorders | Part A Dose Titration: SC (Subcutaneous Apomorphine) | 10 | 97 | 10 |
| other | Fatigue | General disorders | Part B Treatment: APL (APL-130277) | 4 | 71 | 4 |
| other | Fatigue | General disorders | Part B Treatment: SC (Subcutaneous Apomorphine) | 4 | 70 | 5 |
| other | Injection site erythema | General disorders | Part A Dose Titration: APL (APL-130277) | 0 | 102 | 0 |
| other | Injection site erythema | General disorders | Part A Dose Titration: SC (Subcutaneous Apomorphine) | 6 | 97 | 9 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A Dose Titration: APL (APL-130277) | 0 | 102 |
| Total, all-cause mortality | Part A Dose Titration: SC (Subcutaneous Apomorphine) | 0 | 97 |
| Total, all-cause mortality | Part B Treatment: APL (APL-130277) | 0 | 71 |
| Total, all-cause mortality | Part B Treatment: SC (Subcutaneous Apomorphine) | 0 | 70 |
| Total, other adverse events | Part A Dose Titration: APL (APL-130277) | 52 | 102 |
| Total, other adverse events | Part A Dose Titration: SC (Subcutaneous Apomorphine) | 44 | 97 |
| Total, other adverse events | Part B Treatment: APL (APL-130277) | 23 | 71 |
| Total, other adverse events | Part B Treatment: SC (Subcutaneous Apomorphine) | 37 | 70 |
| Total, serious adverse events | Part A Dose Titration: APL (APL-130277) | 0 | 102 |
| Total, serious adverse events | Part A Dose Titration: SC (Subcutaneous Apomorphine) | 1 | 97 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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