Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia

Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition. Treatment of dysphagia by injecting botulinum toxin in the cricopharyngeus was described by Schneider et al. in 1994. More than 100 cases have been described after that, however there are no randomized controlled trials. A meta-analysis from Cochrane has also concluded that there is no sufficient evidence to conclude regarding the efficacy and safety of Botulinum toxin injection in cricopharyngeal dysfunction. So this study is necessary to fill this void in knowledge

NCT Number	NCT04695600
Lead Sponsor	All India Institute of Medical Sciences
Conditions	Transfer Dysphagia, Oropharyngeal Dysphagia, Cricopharyngeus Muscle Dysfunction
Enrollment	100 participants
Start Date	2023-08-11
Primary Completion	2027-08-31 (estimated)
Study Completion	2027-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-07