Clinical trial

Efficacy of Flunarizine Vs Amitriptyline in Prophylaxis of Migraine Prophylaxis

Name

R&ID003

Description

To compare the frequency of acute attack and mean pain score ( assessed by visual analog scale) among subjects using either flunarizine or amitriptyline among patients with migraine coming to tertiary care Hospital in Lahore, Pakistan. In this study 84 patients with migraine Age ranged between 18- 60 years, Both genders having 3 or more migraine attacks per month, normal systemic and neurological examination and not having taken any prophylactic medication for the last 4 months will randomly divided into two equal group of 42 subjects each.

Trial arms

Trial start

2024-01-01

Estimated PCD

2024-06-30

Trial end

2024-09-30

Status

Not yet recruiting

Treatment

Amitriptyline

Amitriptyline will be used for prophylaxis of migraine, also used as antidepressant

Arms:

GroupA

Other names:

Amyline

Flunarizine 5mg

Flunarizine will be used for prophylaxis of migraine,

Arms:

Group B

Other names:

Sibelium

Size

Primary endpoint

Severity of headache

It will be asses at baseline, at 6th week, and at 12th week

No. of Attacks per month

It will be asses at baseline, at 6th week, and at 12th week

Eligibility criteria

Inclusion Criteria: * Age 18- 60 years 2. Both genders 3. 3 or more migraine attacks per month 4. normal systemic and neurological examination 5. not having taken any prophylactic medication for the last 4 months Exclusion Criteria: * Un controlled hypertension 2. Ischemic heart disease, chronic liver failure and chronic liver disease 3. Pregnant patient 4. Known allergies to drug being used in study 5. Major pathology or surgery at the neck or the head 6. Recent injury or road traffic injury at the head or the cervical spine 7. Cancer pain 8. Rheumatological or immune related diseases 9. Implantable metallic or electrical devices in the head 10. Patients using opioids or user of illicit drugs or has had recent history of alcohol or drug abuse.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blind, Randomized Parallel study design, All the consented participants will be randomized into two equal groups', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients with migraine with even No. Medical Record will be assigned Amitriptyline whereas subjects with Odd Medical record No. will be treated with Flunarizine', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}

Updated at

2023-12-29

1 organization

2 products

2 indications

Organization

Shalamar Institute of Health Sciences

Product

Indication

Indication

Product