Dysphagia, Late Effect of StrokePhase 2CADYSNCT04470752
Capsaicin for Post-stroke Dysphagia
A Phase 2 study testing Capsaicin 1% oral solution and InOrpha Solution in people with Dysphagia, Late Effect of Stroke, run by Georg Kägi, MD at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Late Effect of Stroke
- What is being tested?
- Capsaicin 1% oral solution and InOrpha Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Aug 2021to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
About this study
Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.
Read the detailed 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.
- Conditions
- Dysphagia, Late Effect of Stroke
- Being tested
- Capsaicin 1% oral solution, InOrpha Solution
- Keywords
- Dysphagia, Stroke
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 1% oral solutionDrug
Capsaicin 1.0 micrograms/ml
InOrpha SolutionDrug
glycerol based suspension vehicle
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days. Receives: 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. Receives: Drug: Capsaicin 1% oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after randomisation
Secondary outcomes (9)
Functional Oral Intake Scale (FOIS) score
Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)
Measured: at day 7 and 30 post admission
days of nasogastric tube feeding
Between group differences (capsaicin / placebo) of days of nasogastric tube feedings
Measured: 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
Measured: from randomisation until day 30
number of patients with aspiration pneumonia
Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia
Measured: 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)
Measured: from randomisation until day 30
Latency of the Swallowing reflex
Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex
Measured: from randomisation until day 30
modified Ranking Scale (mRS) score
Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)
Measured: 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)
Measured: 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
Measured: after 7 and 30 days post admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start24 Aug 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, Late Effect of StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georg Kägi, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of Aarau, Switzerland, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Georg Kägi, MD, Cantonal Hospital of St. Gallen
- Investigators
- Georg kägi, Dr. med., Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470752
- Sponsor's protocol ID
- BASEC 2020-01362
- Other IDs
- 08.011
- Acronym
- CADYS
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to upload the study protocol after trial completion
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsaicin for Post-stroke Dysphagia
- ClinicalTrials.gov ID
- NCT04470752
- Acronym / sponsor ID
- CADYS / BASEC 2020-01362
- Conditions
- Dysphagia, Late Effect of Stroke
- Keywords
- Dysphagia, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Georg Kägi, MDUniversity, hospital or other
- Collaborators
- Cantonal Hospital of Aarau, Switzerland, University Hospital, Basel, Switzerland
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: InOrpha SolutionInOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days. |
| Capsaicin | Experimental | Drug: Capsaicin 1% oral solutionInOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin 1% oral solutionCapsaicin 1.0 micrograms/ml | Drug | Capsaicin |
| InOrpha Solutionglycerol based suspension vehicle | Drug | Placebo |
Primary outcome
Penetration Aspiration Scale (PAS) score
Time frame: 7 days after randomisation
the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.
9 secondary outcomes
Functional Oral Intake Scale (FOIS) score
Time frame: at day 7 and 30 post admission
days of nasogastric tube feeding
Time frame: from randomisation until day 30
number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement
Time frame: from randomisation until day 30
number of patients with aspiration pneumonia
Time frame: from randomisation until day 30
Swallowing quality of life questionnaire (Swal-QoL) score
Time frame: from randomisation until day 30
Latency of the Swallowing reflex
Time frame: from randomisation until day 30
modified Ranking Scale (mRS) score
Time frame: from randomisation until day 30
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke
Time frame: after 7 and 30 days post admission
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke
Time frame: after 7 and 30 days post admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- PRESS AppLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to upload the study protocol after trial completion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg kägi, Dr. med. principal investigator
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capsaicin 1% oral solution and InOrpha Solution in people with Dysphagia, Late Effect of Stroke, run by Georg Kägi, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg Kägi, Dr.med. (+41 71 494 3594, georg.kaegi@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (PAS) score (time frame: 7 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 28 Oct 2026.