CTRI/2015/05/005829
Completed
Phase 4
Topical betablockers(Timolol ophthalmic solution 0.5 %) in acute migraine-a prospective randomised crossover trial
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Dr Abraham Kurian
- Enrollment
- 50
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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