Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age14+
SponsorAll India Institute of Medical Sciences
About this trial
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
Eligibility criteria
Qualifiers
Patients attending neurology OPD with swallowing dysfunction due to central nervous system dysfunction
At least 14 years of age of all sexes
mRS (modified Rankin scale) of ≤3 at time of study enrolment
In case of post stroke dysphagia, at least 6 months have passed following stroke
Disqualifiers
Diagnosed cases of neuromuscular disorders of the peripheral nervous system and ALS
mRS at time of enrolment >3
Patients with expected life expectancy less than 1 year due to primary disease or co morbidity based on clinical prediction scores
Known allergy to botulinum neurotoxin or its preservatives/excipients
Trial design
Treatments tested in this trial
- Botulinum Toxin Type A Injection [Botox]
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov