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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events Within 72 Hours After Administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •Provision of written informed consent by the participant or legally authorized representative.
排除标准
- •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.
研究组 & 干预措施
Transmucosal Capsaicin
干预措施: Capsaicin Transmucosal Oral Film (Drug)
Placebo Oral Film
干预措施: Placebo Transmucosal Oral Film (Drug)
结局指标
主要结局
Incidence of Adverse Events Within 72 Hours After Administration
时间窗: 72 hours after study intervention 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.
次要结局
- Change in Systolic Blood Pressure Over 72 Hours(Baseline (pre-dose) through 72 hours post-dose)
- Change in Heart Rate Over 72 Hours(Baseline (pre-dose) through 72 hours post-dose)
- Treatment Tolerability Within 72 Hours(Up to 72 hours post-dose)
研究者
Juan Manuel Marquez Romero
Principal investigator
Instituto Mexicano del Seguro Social