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.
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.
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.
Parallel
Capsaicin Transmucosal Oral Film
DrugA 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 Transmucosal Oral Film
DrugA 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.
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.
Change in Systolic Blood Pressure Over 72 Hours
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.
Change in Heart Rate Over 72 Hours
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.
Treatment Tolerability Within 72 Hours
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.
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Instituto Mexicano del Seguro Social
Lead sponsor
Centenario Hospital Miguel Hidalgo
Collaborator
