Safety of Transmucosal Capsaicin Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke

NCT07406971 | Recruiting Phase 2

• 1 other identifier: Cap-SPGAS
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Acute ischemic stroke; Capsaicin; Sphenopalatine ganglion stimulation

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events Within 72 Hours After 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 Outcomes (3)

• Change in Systolic Blood Pressure Over 72 Hours

  Baseline (pre-dose) through 72 hours post-dose

• Change in Heart Rate Over 72 Hours

  Baseline (pre-dose) through 72 hours post-dose

• Treatment Tolerability Within 72 Hours

  Up to 72 hours post-dose

Study Arms (2)

Transmucosal Capsaicin

EXPERIMENTAL

Drug: Capsaicin Transmucosal Oral Film

Placebo Oral Film

PLACEBO COMPARATOR

Drug: Placebo Transmucosal Oral Film

Interventions

Capsaicin Transmucosal Oral Film DRUG

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.

Transmucosal Capsaicin

Placebo Transmucosal Oral Film DRUG

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.

Placebo Oral Film

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Centenario Hospital Miguel Hidalgo: collaborator

Study Sites (1)

Centenario Hospital Miguel Hidalgo

Aguascalientes, Aguascalientes, 20000, Mexico

RECRUITING

Related Publications (2)

• Marquez-Romero JM, Huerta-Franco MR, Vargas-Luna M, Madrigal-Gutierrez CA, Esparza-Hernandez JM, Velazquez-Barcena MG. Dose Escalation and Safety of Capsaicin for Cerebral Perfusion Augmentation: A Pilot Study. Stroke. 2021 Jul;52(7):2203-2209. doi: 10.1161/STROKEAHA.120.032773. Epub 2021 May 10.

  PMID: 33966493 BACKGROUND

• Marquez-Romero JM, Garcia-Perales C, Garcia-Arellano M, Ortiz MS, Perez-Malagon CD, Huerta-Franco MR, Vargas-Luna FM. Capsaicin for Cerebral Perfusion Augmentation: A Randomized Open-Label Trial. Stroke. 2024 Apr;55(4):e112-e114. doi: 10.1161/STROKEAHA.123.046045. Epub 2024 Mar 8. No abstract available.

  PMID: 38456262 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Juan M Marquez-Romero, MD, PhD

CONTACT

+524499136423; scint1st@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning after publication of the primary study results and continuing for up to 5 years thereafter.
• 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.

Locations

ME (1)