Capsaicin for Post-stroke Dysphagia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-24

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Dysphagia, Late Effect of Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Both study drug and Placebo have identical packaging (brown glass bottle) and labeling (Capsaicin or Placebo). Both use the same liquid suspension, same colour, and consistency..

Study Groups

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Placebo

InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.

Group Type PLACEBO_COMPARATOR

InOrpha Solution

Intervention Type DRUG

glycerol based suspension vehicle

Capsaicin

InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.

Group Type EXPERIMENTAL

Capsaicin 1% oral solution

Intervention Type DRUG

Capsaicin 1.0 micrograms/ml

Interventions

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Capsaicin 1% oral solution

Capsaicin 1.0 micrograms/ml

Intervention Type DRUG

InOrpha Solution

glycerol based suspension vehicle

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No