A post marketing, open label, multicentre study to evaluate the safety and efficacy of Fixed Dose Combination of Propranolol Hydrochloride 40 mg plus Flunarizine 5 mg and Fixed Dose Combination of Propranolol Hydrochloride 40 mg plus Flunarizine 10 mg in the prophylaxis of migraine without aura.

AKUMS DRUGS PHARMACEUTICALS LTD0 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

暂无简介。

•1.Patients of either sex, between the ages of 18 to 65 years.
•2.Patients with history of migraine without aura for at least 3 months prior to evaluation of study as per International Classification of Headache Disorders (ICHD)
•3.Patients experience 2-6 migraine attacks per month, but not more than 15 headache days per month.
•4.Patients willing to sign Informed Consent Form.

•1.Patients have more than 15 headache days per month or less than 2 migraine attacks per month.
•2.Pregnant women or nursing mothers.
•3.Women of child-bearing potential & all men not willing to follow a reliable & effective birth control measure during the course of the study & at least 3 months after the last visit.
•4.Patients have commenced any form of migraine prophylactic therapy within 1 month preceding the trial.
•5.Patients need antidepressant medicines.
•6.Patientâ??s headache attacks are associated with or attributable to an identifiable cause, such as: premenstrual period; a disease of eye, ear or nose; a neurological disease or psychosis.
•7.Patients with known history of bronchial asthma.
•8.Patients with known history of dyslipidemia.
•9.Patients with diabetes mellitus, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: beta-blocker, calcium channel blockers, antidepressants or antiepileptics.
•10.Unlikely to maintain a headache diary, comply with the medication or be regular in follow-up visits.
•11.Any serious disease that would interfere with the compliance to the study protocol.

发起方