drugset / Trial / NCT04695600

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

NCT04695600

Phase 2/3 Recruiting 100 enrolled All India Institute of Medical Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2023-08-11
Primary completion
2027-08-31
Completion
2027-09-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Intramuscular