CTRI/2021/01/030809
Not yet recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AIIMS
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients attending neurology OPD with swallowing dysfunction as described above
- •2\. At least 14 years of age of all sexes
- •3\. mRS (modified Rankin scale) of \<\=3 at time of study enrolment
- •4\. In case of post stroke dysphagia, at least 6 months have passed following stroke
- •5\. Willing to undergo swallowing assessment clinically and with video fluoroscopy/barium swallow, flexible upper GI endoscopy and esophageal manometry before and after the injection
- •6\. Above investigations show impaired cricopharyngeal relaxation, adequate pharyngeal strength and antero\-cephalad laryngeal movement
- •7\. Ready to provide consent for botulinum neurotoxin injection.
- •8\. Willing to adhere to protocol and comply with follow up visits
- •9\. No major neurologic or systemic medical condition that reduces life expectancy to less than 1 year based on clinical prediction scores
Exclusion Criteria
- •1\. Diagnosed cases of neuromuscular disorders of the peripheral nervous system and ALS
- •2\. mRS at time of enrolment \>3
- •3\. Patients with expected life expectancy less than 1 year due to primary disease or co\-morbidity based on clinical prediction scores
- •4\. Known allergy to botulinum neurotoxin or its preservatives/excipients
- •5\. Received botulinum toxin for any indication in the last 12 weeks
- •6\. Those with known antibodies against Botulinum neurotoxin A
- •7\. Those who underwent myotomy of the cricopharyngeus muscle
- •8\. Those who had undergone procedures like denervation of the cervical musculature
- •9\. Dysphagia of other causes not fulfilling inclusion criteria
- •10\. Women of childbearing potential who are not using adequate contraception or who are pregnant and lactating
Outcomes
Primary Outcomes
Not specified
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