Capsaicin oral film to stimulate the sphenopalatine ganglion after acute ischemic stroke
Official title: 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
Run by Instituto Mexicano del Seguro Social · NCT07406971 · Data updated 2026-11-12
This trial will test whether a dissolvable capsaicin oral film is safe and tolerable when given within 24 hours to adults with acute ischemic stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Aguascalientes, Aguascalientes) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07406971 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with an acute ischemic stroke presenting within 24 hours, NIHSS score 6–20, and a pre-stroke modified Rankin Scale ≤1 are the intended participants.
✕Probably not a fit
Patients with intracranial hemorrhage, severe impaired consciousness, uncontrolled very high blood pressure, or major systemic illness are excluded and would not be expected to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with acute ischemic stroke (NIHSS 6–20) are randomly assigned in a double-blind design to receive either a low-dose capsaicin transmucosal oral film or a matching placebo film, in addition to standard stroke care. The film is intended to stimulate oral nerves that may activate the sphenopalatine ganglion, a structure involved in regulating cerebral blood flow. The intervention must be started within 24 hours of symptom onset and participants are monitored closely for safety and tolerability outcomes. The main goal of this Phase 2 trial is to determine whether the capsaicin film can be given safely in this acute setting.
Why it matters
Potential benefit: If safe, this simple, noninvasive film could offer a way to modulate blood flow to the brain and potentially improve recovery after ischemic stroke.
How similar studies have gone: Sphenopalatine ganglion stimulation has been explored in small clinical and preclinical studies, but using a dissolvable capsaicin oral film in acute ischemic stroke is largely novel and supported only by preliminary data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Centenario Hospital Miguel Hidalgo
Aguascalientes, Aguascalientes, Mexico Recruiting
Study contacts
- Study coordinator: Juan M Marquez-Romero, MD, PhD
- Email: scint1st@gmail.com
- Phone: +524499136423
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.