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Could a botox shot in the throat restore swallowing after stroke or Parkinson's?

NCT ID NCT04695600

Disease control Sponsor: All India Institute of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial investigates whether injecting Botox into the upper throat muscle (cricopharyngeus) can ease swallowing problems in people with conditions like stroke, multiple sclerosis, or Parkinson's. The muscle normally relaxes during swallowing but can become too tight in these disorders. Researchers will compare Botox injections to a placebo in 100 participants, measuring improvements in swallowing function after three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin A (Botox)
What this could lead to
If effective, Botox injections could offer a non-surgical treatment for swallowing difficulties caused by a tight throat muscle.
What could go wrong
This is an early combined Phase 2/3 trial with 100 participants. Previous studies have been small and inconclusive, so results may not confirm benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders retrograde cricopharyngeus dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cricopharyngeus muscle dysfunction Oropharyngeal dysphagia Transfer dysphagia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All India Institute of Medical Sciences, New Delhi

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

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