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.

VITROBIO SAS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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 productâ??s components.

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