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New treatment option for Transfer Dysphagia
Official title Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia
ClinicalTrials.gov ID: NCT04695600
What this study is testing
What is Botulinum Toxin Type A Injection [Botox]?
Botulinum Toxin Type A Injection [Botox] is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for transfer dysphagia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Delhi, National Capital Territory of Delhi, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Delhi, National Capital Territory of Delhi, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.