Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia
Recruiting
Phase 2
Phase 3
Interventional Study
Transfer Dysphagia
Oropharyngeal Dysphagia
Cricopharyngeus Muscle Dysfunction
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 14 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- All India Institute of Medical Sciences · Other
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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, ho…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 follo…
Contacts