Capsaicin for Post-stroke Dysphagia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Capsaicin for Post-stroke Dysphagia

Conditions
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Dysphagia, Late Effect of Stroke

Intervention / Treatment
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* Drug: Capsaicin 1% oral solution
* Drug: InOrpha Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days. | Drug: InOrpha Solution<br>* glycerol based suspension vehicle<br>|
| Experimental: Capsaicin<br>InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days. | Drug: Capsaicin 1% oral solution<br>* Capsaicin 1.0 micrograms/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration Aspiration Scale (PAS) score | the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission. | 7 days after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Oral Intake Scale (FOIS) score | Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS) | at day 7 and 30 post admission | 
| days of nasogastric tube feeding | Between group differences (capsaicin / placebo) of days of nasogastric tube feedings | from randomisation until day 30 | 
| number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement | Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement | from randomisation until day 30 | 
| number of patients with aspiration pneumonia | Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia | from randomisation until day 30 | 
| Swallowing quality of life questionnaire (Swal-QoL) score | Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL) | from randomisation until day 30 | 
| Latency of the Swallowing reflex | Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex | from randomisation until day 30 | 
| modified Ranking Scale (mRS) score | Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS) | from randomisation until day 30 | 
| Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke | admission of patients with and without sensory deficits (only supratentorial strokes) | after 7 and 30 days post admission | 
| Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke | of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections | after 7 and 30 days post admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Stroke