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Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary completion date: Dec 31, 2023 to Aug 31, 2027v4 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Study completion date: Dec 31, 2023 to Sep 1, 2027
    • Start date: Aug 22, 2023 to Aug 11, 2023
    • Study title revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2021 to Aug 22, 2023
    • Study sites: 0 to 1
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04695600
Lead Sponsor All India Institute of Medical Sciences
Conditions
(from sponsor)		 Transfer Dysphagia, Oropharyngeal Dysphagia, Cricopharyngeus Muscle Dysfunction
Related terms Deglutition Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov