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RECRUITING
NCT04695600
PHASE2/PHASE3

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

Sponsor: All India Institute of Medical Sciences

View on ClinicalTrials.gov

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

Official title: Efficacy and Safety of Onabotulinum Toxin A (Botox) Injections in the Upper Esophageal Sphincter for the Treatment of Pharyngo-esophageal Dysphagia Due to Cricopharyngeal Dysfunction- A Randomized Double Blinded Placebo Controlled Trial

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-08-11

Completion Date

2027-09-01

Last Updated

2026-07-07

Healthy Volunteers

No

Interventions

DRUG

Botulinum Toxin Type A Injection [Botox]

50 units of Botulinum toxin A (Botox, Allergan, CA) under endoscopic guidance will be injected in the cricopharyngeus muscle

Locations (1)

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, India