CTRI/2021/07/034627尚未招募不适用
A Randomized, Double blind, Clinical Trial to evaluate the safety and efficacy of MIGSPRAY (nasal spray) in the prevention of episodic migraines in Migraine patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- VITROBIO SAS
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To evaluate the change from baseline in monthly migraine
研究概览
简要总结
PrimaryObjective:
§ To assess the efficacy ofMIGSPRAY containing combination of two plants extracts, Salix Alba andTanacetum Parthenium in the prevention of episodic migraines in a randomized,double blind clinical trial.
SecondaryObjective:
To assess themigraine duration and intensity, and well tolerability of test product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients having greater than 1-year history of episodic, migraine (with or without aura) with onset prior to 50 years of age, according to diagnostic criteria established by the International Headache Society.
- •2 Migraine history during the prior 6 months must include: a at least 4 migraines per month b no more than 15 migraines per month c Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy and use an acceptable double-barrier method of birth control during the trial.
- •3 Willing and able to treat a minimum of 4 migraines per month with study medication and consistently complete Diary for up to 12 weeks.
- •4 Patient who has not been using a prophylaxis treatment for at least two months prior to the start of the study.
排除标准
- •Patients, >50 years old at migraine onset Pregnant or nursing patients Abuse of crisis treatment Patients having history of cluster or hemiplegic headache Patients having evidence of seizure or major psychiatric disorder Patients having active chronic pain syndrome Patients having Cardiac or hepatic disease Abusing drugs or alcohol Patients having history of a significant mental disorder Patients having hypersensitivity/ history of allergy to any of the Investigational product’s components.
结局指标
主要结局
To evaluate the change from baseline in monthly migraine
时间窗: at day 65
次要结局
- Achievement of at least a 50% reduction from baseline in monthly migraine(at day 65)
- Change from Baseline in acute migraine-specific medication treatment(at day 65)
- Change from Baseline in headache impact scores as measured by the HIT-6(at day 65)
研究者
研究点 (1)
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