A PMS Study of fixed dose combination of Propranolol Hydrochloride plus Flunarizine in the prophylaxis of migraine without aura.

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Frequency of migraine attacks. <br/ ><br>2.Intensity of migraine attacks. <br/ ><br>3.Migraine disability assessed by Migraine Disability Assessment (MIDAS) scale.Timepoint: Day 01; Day 30Â±2; Day 60Â±2; Day 90Â±2

Secondary Outcome Measures

Name	Time	Method
1.Change in percentage of patients with MIDAS grade from baseline to end of the study. <br/ ><br>2.Responder rate of more than 50% reduction in total MIDAS score.Timepoint: Day 01; Day 30Â±2; Day 60Â±2; Day 90Â±2