NCT06356025

Botulinum Toxin Injection in the UES for R-CPD

Botulinum Toxin Injection in the Upper Esophageal Sphincter for Retrograde-cricopharyngeus Dysfunction: a Prospective, Double Blind, Placebo-controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: AZ Delta · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection). This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label.

Conditions

• Retrograde Cricopharyngeus Dysfunction

Interventions

Type	Name	Description
DRUG	botulinum toxin type A	Botulinum toxin type A 75U dissolved in 3mL physiological serum injection in the upper esophageal sphincter
DRUG	Sodium Chloride 0.9% Inj	Placebo: physiological serum 3mL injection in the upper esophageal sphincter

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-12-01
• Completion: 2027-03-01
• First posted: 2024-04-10
• Last updated: 2025-12-08

Locations

1 site across 1 country: Belgium