NCT04470752

Capsaicin for Post-stroke Dysphagia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Georg Kägi, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.

Detailed description

After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES) patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be applied 3 times daily either during meals or during regular swallowing tests/trainings accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7 days, patients with persistent dysphagia and applicable for further treatment will be treated for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A Patient Medication Diary will used during the Duration of the Trial to capture compliance.

Conditions

• Dysphagia, Late Effect of Stroke

Interventions

Type	Name	Description
DRUG	Capsaicin 1% oral solution	Capsaicin 1.0 micrograms/ml
DRUG	InOrpha Solution	glycerol based suspension vehicle

Timeline

• Start date: 2021-08-24
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-07-14
• Last updated: 2023-06-22

Locations

1 site across 1 country: Switzerland