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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Botulinum Toxin Type A Injection [Botox]
Drug50 units of Botulinum toxin A (Botox, Allergan, CA) under endoscopic guidance will be injected in the cricopharyngeus muscle
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Botulinum toxin armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients who have moderate to significant improvement in swallowing function on self assessment and clinical swallowing assessment - 3 weeks
To compare the proportion of patients who have moderate to significant improvement in swallowing function on self assessment and clinical swallowing assessment at 3 weeks post injection amongst those who received onabotulinum toxin (Botox, Allergan, Irvine, CA) and those who received placebo.
Time frame
3 weeksSecondary outcomes
1
Proportion of patients with improvement in swallowing related parameters on video fluoroscopy, flexible endoscopic evaluation of swallowing and esophageal manometry - 3 weeks
To compare the proportion of patients with improvement in swallowing related parameters on video fluoroscopy, flexible endoscopic evaluation of swallowing and esophageal manometry at 3 weeks post injection between Botox group and placebo group
Time frame
3 weeks2
Proportion of patients with improvement in swallowing related parameters on video fluoroscopy, flexible endoscopic evaluation of swallowing and esophageal manometry - 3 months
To compare the proportion of patients with improvement in swallowing related parameters on video fluoroscopy, flexible endoscopic evaluation of swallowing and esophageal manometry at 3 months post injection between Botox group and placebo group
Time frame
3 months3
Adverse effects
To compare the proportion of patients with worsening of dysphagia, vocal cord palsy and other adverse effects upto 3 months post injection
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov