Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia (NCT04695600) | Clinical Trial Compass
UnknownPhase 2/3
Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia
India100 participantsStarted 2023-08-22
Plain-language 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
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who have moderate to significant improvement in swallowing function on self assessment and clinical swallowing assessment - 3 weeks
Timeframe: 3 weeks
2
Proportion of patients who have moderate to significant improvement in swallowing function on self assessment and clinical swallowing assessment - 3 months