NCT04695600 Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia
| NCT ID | NCT04695600 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | All India Institute of Medical Sciences |
| Condition | Transfer Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-08-11 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2023-08-11 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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 following stroke * Willing to undergo swallowing assessment clinically and with video fluoroscopy, flexible upper GI endoscopy and esophageal manometry before and after the injection * Above investigations show impaired cricopharyngeal relaxation, adequate pharyngeal strength and anterocephalad laryngeal movement * Ready to provide consent for Botulinum neurotoxin injection. * Willing to adhere to protocol and comply with follow up visits * No major neurologic or systemic medical condition that reduces life expectancy to less than 1 year based on clinical prediction scores Exclusion Criteria: * 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 * Received botulinum toxin for any indication in the last 12 weeks * Those with known antibodies against Botulinum neurotoxin A * Those who underwent myotomy of the cricopharyngeus muscle * Those who had undergone procedures like denervation of the cervical musculature * Dysphagia of other causes not fulfilling inclusion criteria * Women of childbearing potential who are not using adequate contraception or who are pregnant and lactating * Not willing to provide consent
Contact & Investigator
Arunmozhimaran Elavarasi, MD DM
PRINCIPAL INVESTIGATOR
All India Institute of Medical Sciences
Frequently Asked Questions
Who can join the NCT04695600 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Transfer Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04695600 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04695600 currently recruiting?
Yes, NCT04695600 is actively recruiting participants. Contact the research team at arun_ela@yahoo.com for enrollment information.
Where is the NCT04695600 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT04695600 clinical trial?
NCT04695600 is sponsored by All India Institute of Medical Sciences. The principal investigator is Arunmozhimaran Elavarasi, MD DM at All India Institute of Medical Sciences. The trial plans to enroll 100 participants.