Category: Parkinson’s Disease: Clinical Trials
Objective: Evaluate treatment satisfaction with apomorphine sublingual film (SL-APO) vs subcutaneous apomorphine (SC-APO) for the treatment of OFF episodes in patients with Parkinson’s disease (PD).
Background: Sublingual and subcutaneous apomorphine formulations have been used for the treatment of OFF episodes. Patient satisfaction with SL-APO vs SC-APO has not been systematically evaluated.
Method: An open-label, randomized, crossover study consisting of titration (Part A) and treatment (Part B) phases assessed SL-APO vs SC-APO in patients with PD and OFF episodes. In Part A, both medications were titrated in all patients in a randomly assigned order (SL-APO: 10‒30 mg, 5-mg increments [partial at-home titration]; SC-APO: 2‒6 mg, 1-mg increments [in-clinic titration]) to determine the dose that provided a FULL ON within 30 min. Patients completed a 3‒7 d washout between titrations and at the end of Part A. In Part B, patients were randomized 1:1 to 4 wk of treatment with their optimized dose of SL-APO or SC-APO for up to 5 OFF episodes/d, followed by a washout and 4 wk of crossover treatment. Treatment satisfaction for SL-APO and SC-APO was assessed with the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; 0‒100-point scale, higher values indicated greater satisfaction), and the 4-item Ease of Use Questionnaire (5-point Likert scale). Questionnaires were administered at wk 4 in each treatment period. Endpoints were summarized descriptively.
Results: Overall, 113 and 74 patients were randomized in Part A and B, respectively. Patients reported higher levels of satisfaction on the TSQM for SL-APO vs SC-APO based on convenience (mean [SD]: 73.7 [17.0] vs 53.5 [19.1]) and global satisfaction (63.9 [24.9] vs 57.6 [22.0]), and comparable scores for effectiveness (61.0 [21.7] vs 61.4 [20.1]) and side effects (76.7 [27.9] vs 75.4 [27.2]). Based on the Ease of Use Questionnaire, package opening (35% vs 23%), handling (37% vs 19%), and ability to dose myself (51% vs 24%) were rated as very easy by more patients for SL-APO vs SC-APO, respectively.
Conclusion: In this open-label, randomized, crossover study, patients reported greater global satisfaction and convenience with SL-APO vs SC-APO. These findings suggest that SL-APO may provide an acceptable therapeutic alternative to SC-APO for the treatment of OFF episodes.
To cite this abstract in AMA style:
J. Schwarz, C. Carroll, G. Ebersbach, J. Kulisevsky, A. Tessitore, I. Zhang, A. Bowling, S. Wu, E. Pappert, A. Thach. Apomorphine Sublingual Film Versus Subcutaneous Apomorphine in the Treatment of OFF Episodes in Parkinson’s Disease: Results From an Assessment of Patient Satisfaction [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-versus-subcutaneous-apomorphine-in-the-treatment-of-off-episodes-in-parkinsons-disease-results-from-an-assessment-of-patient-satisfaction/. Accessed June 15, 2025.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-versus-subcutaneous-apomorphine-in-the-treatment-of-off-episodes-in-parkinsons-disease-results-from-an-assessment-of-patient-satisfaction/