Capsaicin for Post-stroke Dysphagia (CADYS)

G

Georg Kägi, MD

Status and phase

Enrolling
Phase 2

Conditions

Dysphagia, Late Effect of Stroke

Treatments

Drug: InOrpha Solution
Drug: Capsaicin 1% oral solution

Study type

Interventional

Funder types

Other

Identifiers

NCT04470752
08.011 (Other Identifier)
BASEC 2020-01362

Details and patient eligibility

About

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

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

82 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.
Treatment:
Drug: InOrpha Solution
Capsaicin
Experimental group
Description:
InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.
Treatment:
Drug: Capsaicin 1% oral solution

Trial contacts and locations

1

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Central trial contact

Anna Müller, RN; Georg Kägi, Dr.med.

Data sourced from clinicaltrials.gov

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