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

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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/07/026417

Enrollment

200

Registered

2020-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G430- Migraine without aura

Interventions

Intervention1: Fixed Dose Combination of Propranolol Hydrochloride IP 40 mg (as sustained release) and Flunarizine 5 mg: One uncoated bilayered tablet containing propranolol hydrochloride IP 40 mg (as

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Frequency of migraine attacks. 2. Intensity of migraine attacks. 3. Migraine disability assessed by Migraine Disability Assessment (MIDAS) scale.Timepoint: Day 01; Day 30Â±2; Day 60Â±2; Day 90Â±2	—

Secondary

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

Countries

India

Contacts

Public ContactDr Aditi Datta

Biosite Research Private Limited

aditi.datta@biositeindia.com08026667707

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026