Safety of Transmucosal Capsaicin Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke (Cap-SPGAS)

February 12, 2026 updated by: Juan Manuel Marquez Romero, Instituto Mexicano del Seguro Social

Safety of Transmucosal Capsaicin for Chemical Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke Within 24 Hours of Symptom Onset: A Randomized Double-Blind Placebo-Controlled Trial

This study will evaluate the safety and tolerability of a dissolvable oral film containing a very small dose of capsaicin (the compound that produces the "hot" sensation in chili peppers) in adults with acute ischemic stroke. The film is designed to stimulate nerves in the mouth that may activate the sphenopalatine ganglion, a structure involved in regulating blood flow to the brain. The main purpose of this study is to determine whether the capsaicin film can be given safely to patients with acute ischemic stroke when started within 24 hours of symptom onset.

Participants will be randomly assigned (like flipping a coin) to receive either the capsaicin oral film or a placebo film that looks and tastes similar but contains no capsaicin. Neither the participants nor the clinical team will know which film is given (double-blind). All participants will continue to receive standard medical care for acute ischemic stroke.

After administration of the study film, participants will be closely monitored for side effects and changes in vital signs (blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation) at prespecified time points up to 72 hours. The primary outcome is the frequency of adverse events related to the study product within 72 hours after treatment begins. Participants will also be followed clinically up to 3 months as part of usual stroke care.

The results of this study will help determine whether this approach is safe and feasible, and whether further studies are warranted.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan M Marquez-Romero, MD, PhD
  • Phone Number: +524499136423
  • Email: scint1st@gmail.com

Study Locations

  • Mexico
    • Aguascalientes
      • Aguascalientes, Aguascalientes, Mexico, 20000
        • Recruiting
        • Centenario Hospital Miguel Hidalgo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 80 years.
  • National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20 at screening.
  • Symptom onset within 24 hours prior to study intervention.
  • Pre-stroke modified Rankin Scale (mRS) score ≤1.
  • Provision of written informed consent by the participant or legally authorized representative.

Exclusion Criteria:

  • Intracranial hemorrhage on neuroimaging.
  • Severe impairment of consciousness judged by the investigator to preclude safe participation.
  • Persistent blood pressure >220/120 mmHg after initial medical management.
  • Severe systemic disease that, in the investigator's judgment, may interfere with study participation or safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transmucosal Capsaicin
Drug: Capsaicin Transmucosal Oral Film
A dissolvable transmucosal oral film containing a low dose of capsaicin designed for local administration in the oral cavity. The formulation is intended to provide controlled mucosal exposure to capsaicin for investigational neuromodulatory stimulation of trigeminal-parasympathetic pathways potentially involved in cerebral blood flow regulation. The film is administered once under clinical supervision in addition to standard medical care for acute ischemic stroke.
Placebo Comparator: Placebo Oral Film
Drug: Placebo Transmucosal Oral Film
A dissolvable transmucosal oral film identical in appearance, texture, and administration method to the active study film but without capsaicin. The placebo film is administered once under clinical supervision in addition to standard medical care for acute ischemic stroke to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events Within 72 Hours After Administration
Time Frame: 72 hours after study intervention administration
The primary outcome is the proportion of participants experiencing any adverse event within 72 hours after administration of the study oral film. Adverse events include any unfavorable clinical sign, symptom, or change in vital signs temporally associated with study treatment, regardless of causality. Vital signs (blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation) are recorded at predefined time points during the first 72 hours.
72 hours after study intervention administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure Over 72 Hours
Time Frame: Baseline (pre-dose) through 72 hours post-dose
Change in systolic blood pressure (mmHg) from baseline (pre-dose) to each prespecified post-dose assessment time point through 72 hours. Values will be summarized by treatment group.
Baseline (pre-dose) through 72 hours post-dose
Change in Heart Rate Over 72 Hours
Time Frame: Baseline (pre-dose) through 72 hours post-dose
Change in heart rate (beats per minute) from baseline (pre-dose) to each prespecified post-dose assessment time point through 72 hours. Values will be summarized by treatment group.
Baseline (pre-dose) through 72 hours post-dose
Treatment Tolerability Within 72 Hours
Time Frame: Up to 72 hours post-dose
Proportion of participants who complete the assigned study oral film administration without discontinuation due to intolerance, and incidence of local tolerability symptoms (e.g., oral burning/irritation, excessive salivation, cough) within 72 hours after administration.
Up to 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Collaborators

Centenario Hospital Miguel Hidalgo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cap-SPGAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, subject to institutional approval, data use agreements, and applicable privacy regulations.

IPD Sharing Time Frame

Beginning after publication of the primary study results and continuing for up to 5 years thereafter.

IPD Sharing Access Criteria

Requests should include a methodologically sound proposal. Data sharing will require approval by the study investigators and execution of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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