Capsaicin for Post-stroke Dysphagia

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georg Kägi, MD
• Collaborators: Cantonal Hospital of Aarau, Switzerland; University Hospital, Basel, Switzerland
• Treatments: Capsaicin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Acute ischemic Stroke

• Impairment of oral intake with FOIS ≤ 4

• Magnetic Resonance Imaging of the brain or CT scan with the finding of a subacute ischemic stroke

• Informed Consent within 48 hours after admission, following initial swallowing assessment

Exclusion Criteria:

• Diagnosis other than ischemic stroke

• Late patient admission >48 hours after stroke onset

• Impairment of functional oral intake scale ≥ 5

• FEES >72h after admission

• PAS <2

• Pre-existing dysphagia

• Dysphagia due to other cause

• No evidence of stroke on imaging

• Recurrent stroke = at least one stroke in the course of the study apart from the index stroke

• Age <18 years

• Current drug abuse

• Amphetamine or amphetamine-like Medication

• Regular oral treatment with chilli pepper extract

• Allergies or known adverse reactions to the consumption of chilli pepper or capsaicin

• Personality disorder

• Severe dementia or delirium

• Other reasons according to physician/investigator because of which the patient cannot participate in the study (not suitable for treatment or examinations)

• withdrawal of consent by participant at any time of the study