{"doi":"10.1177/17562864231209240","title":"Feasibility of home dose optimization of apomorphine sublingual film in Parkinson’s disease patients with OFF episodes: results from the dose-optimization phase of an open-label, randomized crossover study","abstract":"Background: Dose optimization of sublingual apomorphine (SL-APO), a dopamine agonist for the treatment of OFF episodes in patients with Parkinson's disease (PD), has been performed under clinical supervision in clinical trials. SL-APO may be a candidate for home dosing optimization which would be less burdensome for patients. Objectives: To evaluate the feasibility and safety of home optimization of SL-APO in patients with PD and OFF episodes. Design: A multicenter, randomized, crossover study comparing SL-APO with subcutaneous apomorphine was conducted, comprising an open-label dose-optimization phase and a treatment phase. This non-comparative analysis focuses on the outcomes of the dose-optimization phase with SL-APO only. Methods: telephone. Patients reporting a FULL ON returned to the clinic for a dose-confirmation visit (DCV). In patients with inadequate response as determined during the DCV, the dose could be further optimized at home. Results: Home optimization was continued by 81.4% (83/102) of patients. Of these, 80.7% identified an effective, tolerable dose. Mean time between initial clinic visit and DCV 1 was 6.8 days, and the final optimized dose of SL-APO was 30 mg (mode). In total, 62.7% of patients reported ⩾1 adverse event; the most common included nausea (31.4%), dizziness (9.8%), somnolence (8.8%), dyskinesia (7.8%), and fatigue (5.9%). The safety profile in this study in which most patients performed home dose optimization was consistent with the study utilizing clinic-based optimization. Conclusion: After the first clinic dose, home dose optimization of SL-APO appears feasible in patients with PD and OFF episodes, with most patients identifying their optimal SL-APO dose at home. Trial registration: This study is registered with EudraCT (2016-003456-7): Clinical Trials register - Search for eudract_number:2016-003456-70.","journal":"Therapeutic Advances in Neurological Disorders","year":2023,"id":367598,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":5,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9546,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":876109,"name":"Fabrizio Stocchi","orcid":"0000-0002-5763-0033","position":1,"is_corresponding":false},{"id":1125647,"name":"Ernest Balaguer Martinez","orcid":null,"position":2,"is_corresponding":false},{"id":473073,"name":"Rajesh Pahwa","orcid":"0000-0003-3176-6466","position":3,"is_corresponding":false},{"id":309339,"name":"William G. Ondo","orcid":"0000-0001-6090-4261","position":4,"is_corresponding":false},{"id":333859,"name":"Yi Zhang","orcid":"0000-0002-7422-8206","position":5,"is_corresponding":false},{"id":1054073,"name":"Alyssa Bowling","orcid":"0000-0001-9974-9182","position":6,"is_corresponding":false},{"id":1125648,"name":"Eric J. Pappert","orcid":null,"position":7,"is_corresponding":false},{"id":309338,"name":"Stuart Isaacson","orcid":"0000-0002-9914-5706","position":8,"is_corresponding":false},{"id":1125185,"name":"Stacy Wu","orcid":"0009-0000-8486-5893","position":9,"is_corresponding":false},{"id":1125649,"name":"for the CTH-302 Study Investigators*","orcid":null,"position":10,"is_corresponding":false},{"id":652251,"name":"Jan Kassubek","orcid":"0000-0002-7106-9270","position":0,"is_corresponding":true}],"reference_count":9,"raw_metadata":null,"created_at":"2026-07-19T01:15:16.306414Z","pmid":"37954918","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}