Category: Parkinson’s Disease: Clinical Trials
Objective: Evaluate the ability of patients with Parkinson’s disease (PD) and OFF episodes to achieve an effective and tolerable FULL ON dose of apomorphine sublingual film (SL-APO) when titration is performed at home.
Background: SL-APO is used for the treatment of OFF episodes in patients with PD. Prior clinical studies of SL-APO required in-clinic titration to identify the optimal dose to convert patients from OFF to FULL ON.
Method: An open-label, randomized, crossover study assessed SL-APO versus subcutaneous apomorphine in patients with PD and OFF episodes. For SL-APO titration, patients presented to the clinic in a practically defined OFF and received a 10-mg dose. If a patient failed to achieve a FULL ON within 30 min, up-titration during subsequent OFF episodes could continue at home without in-person supervision using 5-mg dose increases of SL-APO until the patient felt that an optimal response was achieved (30-mg dose maximum). Thereafter, patients returned to clinic for a dose-confirmation visit (DCV), during which the investigator could increase or decrease the dose if necessary. Clinic staff contacted patients daily during home titration to monitor progress and assess tolerability.
Results: Overall, 102 patients underwent open-label SL-APO titration. Twelve patients achieved a FULL ON at 10 mg during the clinic visit, 7 patients did not undergo home titration, and 83 patients continued titration at home. Of the 83 patients who continued titration at home, 67 (81%) completed SL-APO titration. Of these 67 patients, 38 (57%) had their dose confirmed at the DCV, 15 (22%) had their dose decreased at the DCV, and 11 (16%) had their dose increased (1 increased at the DCV and 10 had a subsequent increase after the DCV). One patient did not complete a DCV and was discontinued from the study. Two patients discontinued due to lack of efficacy after home titration and a DCV had been completed. Sixteen patients discontinued during home titration (lack of efficacy after reaching 30 mg dose, n=13; adverse event, n=1 [hyperhidrosis/vomiting]; withdrawal, n=1; other, n=1).
Conclusion: In this open-label, randomized, crossover study, following an initial clinic visit, most patients were able to titrate SL-APO at home without supervision, with dose adjustment occurring in some cases.
To cite this abstract in AMA style:J. Kassubek, F. Stocchi, E. Balaguer, S. Isaacson, I. Zhang, A. Bowling, S. Wu, E. Pappert. Apomorphine Sublingual Film Titrated at Home in Patients With Parkinson’s Disease and OFF Episodes: Results From an Open-Label, Randomized, Crossover Study [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-titrated-at-home-in-patients-with-parkinsons-disease-and-off-episodes-results-from-an-open-label-randomized-crossover-study/. Accessed September 23, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-titrated-at-home-in-patients-with-parkinsons-disease-and-off-episodes-results-from-an-open-label-randomized-crossover-study/