Session Information
Date: Thursday, June 8, 2017
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective:
To determine the dose of APL-130277 required by each patient with Parkinson’s Disease (PD) to turn from OFF to Full ON. This dose is to be utilized in the Phase 3 double-blind, placebo-controlled trial (Maintenance Treatment Phase (MTP).
Background:
Patients with Parkinson’s disease (PD) frequently develop problematic OFF episodes despite optimization of therapies. APL-130277 (apomorphine) is administered sublingually and being studied for OFF episodes.
Methods:
The open-label dose titration phase (DTP) was conducted to determine the appropriate dose of APL-130277 for each patient in the double-blind, placebo-controlled MTP. Patients with PD who had well-defined early AM OFF episodes and total OFF time >2hours/day were enrolled. Patients were evaluated in the OFF period. The titration sequence for APL-130277 was 10mg, 15mg, 20mg, 25mg and 30mg. After the dose was administered the MDS-UPDRS Part III was obtained at 15, 30, 45, 60 and 90 minutes. Patients who responded with a full ON within 45 mins could move to the MTP. Patients who did not achieve a full ON returned to the clinic 3 days (+/-2d) for the next titration dose (i.e., 15mg). The process was repeated until patients achieved a full ON within 45 mins or reached 35mg.
Results:
Preliminary efficacy data are available for the 76 patients (46 men, 30 women) who have completed the DTP and responded to treatment. The median MDS-UPDRS Part III (OFF) was 41.9. The mean number of daily OFF episodes was 3.7. The median dose to turn patients fully ON was 20 mg. 81% of patients who entered the DTP turned fully ON with APL-130277. For responders, the onset of clinical benefit (patient assessment) was 5-12 minutes. 22% of patients turned fully ON by 15 minutes and 59% by 30 minutes. At 30 and 90 minutes there was a 22 and 16-point improvement in the MDS-UPDRS Part III, respectively.
Conclusions:
In this preliminary analysis of this study, APL-130277 provided rapid improvement in patients with PD in the OFF state. The onset of clinical benefit appeared within 5-12 mins and was sustained over 90 mins.
To be presented at: 1st Pan American Parkinson’s Disease and Movement Disorders Congress (February 24-26, 2017; Miami, FL)
To cite this abstract in AMA style:
R. Hauser, S. Isaacson, A. Espay, R. Pahwa, D. Truong, E. Pappert, P. Gardzinski, B. Dzyngel, A. Agro, H. Fernandez. Efficacy of sublingual apomorphine film (APL-130277) for the treatment of OFF episodes in patients with Parkinson’s disease: results from the Phase 3 study dose-titration phase [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/efficacy-of-sublingual-apomorphine-film-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease-results-from-the-phase-3-study-dose-titration-phase/. Accessed June 15, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-sublingual-apomorphine-film-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease-results-from-the-phase-3-study-dose-titration-phase/