Capsaicin for Post-stroke Dysphagia (CADYS)

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