A clinical trial to study the effect of Timolol eyedrops in patients with acute migraine

Phase 4

Completed

• Conditions: Health Condition 1: null- MigraineHealth Condition 2: G439- Migraine, unspecified

• Registration Number: CTRI/2015/05/005829
• Lead Sponsor: Dr Abraham Kurian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-10-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified