NCT07406971

Safety of Transmucosal Capsaicin Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-30
• Completion: 2026-10-31
• First posted: 2026-02-12
• Last updated: 2026-02-17

Locations

1 site across 1 country: Mexico