Safety of Transmucosal Capsaicin Sphenopalatine Ganglion Stimulation in Acute Ischemic Stroke

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Incidence of Adverse Events Within 72 Hours After Administration [Срок оценки: 72 hours after study intervention administration]

Вторичные конечные точки (3)

• Change in Systolic Blood Pressure Over 72 Hours [Срок оценки: Baseline (pre-dose) through 72 hours post-dose]
• Change in Heart Rate Over 72 Hours [Срок оценки: Baseline (pre-dose) through 72 hours post-dose]
• Treatment Tolerability Within 72 Hours [Срок оценки: Up to 72 hours post-dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Centenario Hospital Miguel Hidalgo — Aguascalientes

Публикации

• 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
• 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

Идентификаторы

NCT: NCT07406971 · Cap-SPGAS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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