Session Time: 12:30pm-2:00pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: Determine the minimum MDS-UPDRS Part III improvement needed to convert a patient from the morning OFF state to a full ON with APL-130277.
Background: APL-130277 is a sublingual film being studied in Phase 3 trials to rapidly turn patients ON from OFF episodes by delivering apomorphine via the oral mucosa.
Methods: PD patients with at least one OFF episode/day, = or > 2 hours of daily OFF and experienced a predictable OFF episode each morning upon awakening prior to receiving morning dose of levodopa were included. Patients were dosed in the morning OFF state, starting with APL-130277 10 mg and increased in 5 mg increments until a full ON was achieved, to a maximum of 30 mg. MDS-UPDRS Part III and ON/OFF status was determined pre-dose and 15, 30, 45, 60 and 90 minutes after dosing.
Results: Of the 19 patients dosed, 15 converted from OFF to full ON with APL-130277. For the patients who responded within 15 minutes, the mean change in the MDS-UPDRS Part III at 15 minutes post-dose was -12.3 points and the mean % change was -33%. For the patients who responded at a time > 15 minutes but within 30 minutes, the mean change in the MDS-UPDRS Part III 15 minutes post-dose was -11.7 points and the mean % change was -28%. For those 4 patients who did not respond, the mean change on the MDS-UPDRS Part III 15 minutes post-dose was -10 and the mean % change was -19%
|Groups||MDS-UPDRS Part III Mean Change from Baseline at 15 Minutes||MDS-UPDRS Part III Mean % Change from Baseline at 15 Minutes|
|Responders within 15 minutes (N=6)||-12.3||-33%|
|Responders > 15 minutes but within 30 minutes (N=9)||-11.7||-28%|
Conclusions: A MDS-UPDRS Part III improvement of over 10 points and a change of at least 20 % at 15 minutes post-dose was needed to turn a PD patient from the morning OFF state to a full ON state. Phase 3 studies are ongoing to further evaluate efficacy and safety of APL-130277.
Presented, in part, at the XXI World Congress on Parkinson’s disease and Related Disorders (December 6-9, 2015; Milan, Italy). P 2.090 Minimum MDS-UPDRS part III change needed to convert a Parkinson’s disease patient from the OFF to full ON state with sublingual apomorphine (APL-130277) J. Dubow, B. Dzyngel, T. Bilbault, A. Giovinazzo, A. Agro (Canada).
To cite this abstract in AMA style:H. Shill, A. Agro, E.J. Pappert, B. Dzyngel, T. Bilbault, S. Isaacson, R. Hauser. Minimum MDS-UPDRS part III change needed to convert a Parkinson’s disease patient from the OFF to full ON state with apomorphine sublingual film (APL-130277) [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/minimum-mds-updrs-part-iii-change-needed-to-convert-a-parkinsons-disease-patient-from-the-off-to-full-on-state-with-apomorphine-sublingual-film-apl-130277/. Accessed December 7, 2023.
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