Topical betablockers(Timolol ophthalmic solution 0.5 %) in acute migraine-a prospective randomised crossover trial

Dr Abraham Kurian0 个研究点目标入组 50 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.Male of female patients at least 12 years of age.
•2.Female of childbearing potential should use a reliable form of contraception throughout the study period.
•3.A negative urine pregnancy test result at Enrolment on Day 1 for women of childbearing potential.
•4.Written informed consent to be obtained.
•5.Clinical diagnosis of migraine -Migraine with aura(1.1), Migraine without aura(1.2), Probable Migraine without aura(1.5.1) or Probable Migraine with aura(1.5.2) according to the ICHD III diagnostic criteria.
•6.Not be on any antimigraine medications for atleast 1 month.
•7.Ability to understand and follow the study instructions you receive and willingness for 7 months followup.

•1.Known Allergy or hypersensitivity to the study medications.
•2.Female patients who are pregnant, Breastfeeding, or planning to become pregnant during the study.
•3.Females in childbearing age who are not using a reliable means of contraception
•4.Patients with Bronchial Asthma, Bradyarrhythmias and cardiac dysfunction
•5.Patients with coexistent Glaucoma, in whom use of topical Betablockers is anticipated.
•6.Patients not amenable to a minimum followup of 7 months
•7.Patients on medications for migraine, who were not willing to stop existing treatment for atleast 1 month.
•8.Obstruction of lacrimal drainage system detected on baseline evaluation.
•9.Current enrolment in another investigational study or participation in such a study within 30 days of entry into this study.
•10.Patient has a condition or situation which in the investigators opinion, may put the patient at a significant risk, may confound the study results, or interfere with the participation in the study

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