Category: Parkinson’s Disease: Clinical Trials
Objective: Assess impact of apomorphine sublingual film (APL) on impulse control disorders (ICDs) in patients with Parkinson’s disease (PD) and “OFF” episodes.
Background: In a 12-wk pivotal study, APL was efficacious and generally well tolerated for on-demand treatment of “OFF” episodes in patients with PD. However, dopaminergic agents have been associated with ICDs.
Method: An ongoing, open-label, Phase 3 study (NCT02542696) to evaluate the long-term safety (LTS) and efficacy of APL enrolled patients with PD (new or rollover from prior Phase 2/3 studies) and “OFF” episodes on stable PD medications. APL dose titration occurred in patients who were “OFF” to determine the effective and tolerable dose (10–35 mg; 5-mg increments) that converted them to FULL “ON” within 45 min. In the LTS phase, patients self-administered their titrated APL dose for up to 5 “OFF” episodes/d. ICDs were assessed using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease – Rating Scale (QUIP-RS). Results were summarized descriptively and assessed at wks 24, 36, and 48. TEAEs associated with ICDs were also evaluated.
Results: This analysis (data cut 30Sep2020) evaluated 397 patients (median [range] exposure to APL was 169 [1–1181] d; 1.8 mean doses/d; highest dose received in the LTS phase, 10/15/20/25/30/35 mg: 18%/23%/23%/18%/11%/7%). In the LTS phase, mean (SD) baseline total ICD score was 5.4 (6.61) and changes from baseline were –0.2 (6.29), –0.5 (8.15), and –0.5 (7.54) at wks 24, 36, and 48, respectively. Mean (SD) baseline total QUIP-RS score was 10.0 (11.96) and changes from baseline were –1.7 (11.76), –2.9 (15.28), and –2.0 (16.53) at wks 24, 36, and 48, respectively. The incidence of individual ICD behaviors decreased or remained similar from screening to wk 48: gambling (14% vs 16%), sex (47% vs 34%), buying (40% vs 30%), eating (54% vs 37%), hobbyism/punding (53% vs 37%), and medication use (41% vs 34%). TEAEs associated with ICDs were infrequent during the LTS phase and occurred in <1% of patients, consistent with a prior safety analysis in 459 unique patients with PD who received ≥1 dose of APL where TEAEs of gambling and impulsive behavior each occurred at 0.2%.
Conclusion: The repeated and chronic use of apomorphine sublingual film as an on-demand treatment for “OFF” episodes in patients with PD had minimal impact on ICDs over a period of up to 48 wks in the long-term study.
To cite this abstract in AMA style:A. Espay, K. Markopoulou, I. Zhang, E. Pappert, B. Navia. Apomorphine Sublingual Film for “OFF” Episodes in Parkinson’s Disease: Impact on Impulse Control Disorders [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-off-episodes-in-parkinsons-disease-impact-on-impulse-control-disorders/. Accessed December 7, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-off-episodes-in-parkinsons-disease-impact-on-impulse-control-disorders/