Capsaicin oral film to stimulate the sphenopalatine ganglion after 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
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Aguascalientes, Aguascalientes) |
| Trial ID | NCT07406971 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aguascalientes, Aguascalientes
- Centenario Hospital Miguel Hidalgo — Aguascalientes, Aguascalientes, Mexico (Recruiting)
Study contacts
- Study coordinator: Juan M Marquez-Romero, MD, PhD
- Email: scint1st@gmail.com
- Phone: +524499136423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.