Capsaicin for Post-stroke Dysphagia

NCT04470752 | Unknown Phase 2

• 2 other identifiers: BASEC 2020-0136208.011
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia, Late Effect of Stroke

Keywords

Dysphagia; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Functional Oral Intake Scale (FOIS) score

  at day 7 and 30 post admission

• days of nasogastric tube feeding

  from randomisation until day 30

• number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement

  from randomisation until day 30

• number of patients with aspiration pneumonia

  from randomisation until day 30

• Swallowing quality of life questionnaire (Swal-QoL) score

  from randomisation until day 30

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (safety and tolerability)

  30 days post admission

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: InOrpha Solution

Capsaicin

EXPERIMENTAL

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

Interventions

Capsaicin 1% oral solution DRUG

Capsaicin 1.0 micrograms/ml

Capsaicin

InOrpha Solution DRUG

glycerol based suspension vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georg Kägi, MD: lead
• Cantonal Hospital of Aarau, Switzerland: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Related Links

• PRESS App

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Capsaicin; Solutions

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Pharmaceutical Preparations

Study Officials

• Georg kägi, Dr. med.

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg Kägi, Dr.med.

CONTACT

+41 71 494 3594; georg.kaegi@kssg.ch

Anna Müller, RN

CONTACT

+41 71 494 2958; anna.mueller2@kssg.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physician and Head of the Stroke Center

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: July 14, 2020
• Study Start: August 24, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after Trial completion indefinitely

Locations

CH (1)