{"doi":"10.1001/jamaneurol.2019.4565","title":"Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults","abstract":"Importance: RimabotulinumtoxinB (RIMA) may be preferable as an anti-sialorrhea treatment compared with current oral anticholinergic drugs in people with neurological disorders. Objective: To assess the safety, efficacy, and tolerability of RIMA injections for the treatment of sialorrhea in adults. Design, Setting, and Participants: This randomized, parallel, double-blind, placebo-controlled clinical trial of RIMA 2500 U and 3500 U was conducted from November 14, 2013, to January 23, 2017. A total of 249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened. Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled. Patients had to have a minimum unstimulated salivary flow rate (USFR) of 0.2 g/min and a minimum Drooling Frequency and Severity Scale score of 4. Exposures: Patients were randomized 1:1:1 to RIMA, 2500 U (n = 63); RIMA, 3500 U (n = 64); or placebo (n = 60). Main Outcomes and Measures: Primary outcomes were the change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C) at week 4. The CGI-C scores were recorded on a 7-point scale ranging from very much improved to very much worse. Adverse events were recorded throughout the trial period. Results: Of 187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years), 122 patients had Parkinson disease (65.2%), 13 (7.0%) were stroke survivors, 12 had amyotrophic lateral sclerosis (6.4%), 6 had medication-induced sialorrhea (3.2%), 4 had adult cerebral palsy (2.1%), and 30 had sialorrhea owing to other causes (16.0%). A total of 176 completed the study. Treatment with both doses of RIMA significantly reduced USFR at week 4 vs placebo (mean treatment difference, -0.30 g/min [95% CI, -0.39 to -0.21] for both doses vs placebo, P < .001). The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14 [95% CI, -1.49 to -0.80] for 3500 U, both P < .001). Treatment benefits were seen as early as 1 week after injection and were maintained over the treatment cycle of approximately 13 weeks. The RIMA injections were well tolerated compared with placebo. The most common adverse events were self-limited mild to moderate dry mouth, dysphagia, and dental caries. Conclusions and Relevance: Treatment with RIMA (2500 U and 3500 U) in adults was well tolerated and reduced sialorrhea, with the onset of the effect at 1 week after the injection. These data support the clinical use of RIMA in the management of sialorrhea in adults. Trial Registration: ClinicalTrials.gov Identifier: NCT01994109.","journal":"JAMA Neurology","year":2020,"id":58959,"datarank":2.5188141842196488,"base_score":4.248495242049359,"endowment":4.248495242049359,"self_citation_contribution":0.637274286307404,"citation_network_contribution":1.8815398979122446,"self_endowment_contribution":0.637274286307404,"citer_contribution":1.8815398979122446,"corpus_percentile":null,"corpus_rank":null,"citation_count":69,"citer_count":59,"citers_with_citation_signal":44,"citers_with_endowment":44,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9625,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT01994109"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":309339,"name":"William G. Ondo","orcid":"0000-0001-6090-4261","position":1,"is_corresponding":false},{"id":226513,"name":"Carlayne E. Jackson","orcid":"0000-0002-9368-395X","position":2,"is_corresponding":false},{"id":310204,"name":"Richard Trosch","orcid":null,"position":3,"is_corresponding":false},{"id":243534,"name":"Eric Molho","orcid":null,"position":4,"is_corresponding":false},{"id":269680,"name":"Fernando Pagán","orcid":"0000-0002-4052-156X","position":5,"is_corresponding":false},{"id":310205,"name":"Mark Lew","orcid":null,"position":6,"is_corresponding":false},{"id":309340,"name":"Khashayar Dashtipour","orcid":"0000-0003-3547-0443","position":7,"is_corresponding":false},{"id":310206,"name":"Thomas Clinch","orcid":null,"position":8,"is_corresponding":false},{"id":233015,"name":"Alberto J. Espay","orcid":"0000-0002-3389-136X","position":9,"is_corresponding":false},{"id":310207,"name":"for the MYSTICOL Study Group","orcid":null,"position":10,"is_corresponding":false},{"id":309338,"name":"Stuart Isaacson","orcid":"0000-0002-9914-5706","position":0,"is_corresponding":true}],"reference_count":35,"raw_metadata":null,"created_at":"2026-07-18T21:07:33.416320Z","pmid":"31930364","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":[]}