Efficacy of Flunarizine Vs Amitriptyline in Prophylaxis of Migraine Prophylaxis

December 26, 2023 updated by: Shalamar Institute of Health Sciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Migraine is a genetically influenced complex disorder characterized by episodes of moderate-to-severe headache, most often unilateral and generally associated with nausea and increased sensitivity to light and sound. Migraine is a common cause of disability and loss of work. Migraine attacks are complex brain events that unfold over hours to days in a recurrent matter. Migraine can be classified into subtypes according to the headache classification committee of the International Headache Society these subtypes include migraine without aura, migraine with aura and chronic migraine. Etiology of migraine in related to genetic, dietary and environmental factors. Acute migraine attack is characterized in to four phases of prodrome, aura headache and postdrome. Migraine has an approximate prevalence of 14.7% globally, making it the third most common disease in the world. It occurs three times more commonly in women as compared to men, which is most probably due to hormonal differences. The migraine attacks were most frequently triggered by sleep disturbance (70.5%), stress (66.7%), fatigue (64.4%), excess screen time (61.1%), loud noise (58.8%), dehydration (49.9%), and missed meals or dieting (49.1%). Other common triggering factors were traveling (39.9%), bright sunshine (39.2%), and certain smells or perfume (30.8%). The migraine attacks were triggered by smoking in only 8.1% of the migraineurs and by exercise in only 10.4% of the migraineurs.4 The global prevalence of migraine has increased substantially over the last three decades. According to the Global Burden of Disease (GBD) 2019 study, the estimated global prevalence of migraine increased from 721.9 million in 1990 to 1.1 billion in 2019. Treatment of migraine is divided into abortive measures for an acute attack and prophylactic measures to decrease frequency, severity and duration of attacks. Acute treatment aims to stop the progression of a headache quickly and therapy consists of stratified options of pharmacological and non-pharmacological measures, these include non-steroidal anti-inflammatory drugs, triptans, ergot derivate, dexamethasonse, Transcutaneous electrical nerve stimulation (TENS) therapy and occipital nerve block.

Recent studies have emphasized the role of prophylactic treatment of migraine because once an acute attack occurs, it often incapacitating its sufferers, reduce quality of life and cause significant disability. Preventive treatment aims to reduce attack frequency, improve responsiveness to acute attacks severity and duration, and reduce disability. Indications for preventive treatment include but not limited to frequent or long-lasting headaches, failure of acute therapy, and migraine with complications. Preventive treatment agents include beta blockers e.g. metoprolol and propranolol - especially in hypertensive and non-smoker patients, anti-depressants, amitriptyline and venlafaxine - especially in patients with depression or anxiety disorders and insomnia, Anticonvulsants: valproate acid and topiramate - especially in epileptic patients and Calcitonin gene-related peptide antagonists: erenumab, fremanezumab, and galcanezumab. Along with pharmacological measures life style changes must be a commitment from patient and these include regular exercise, avoidance of dietary triggers and cognitive-behavioural therapy

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54840
        • Shalamar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GroupA
Amitriptyline group will be assessed at baseline and will be followed up at 6th week after treatment and at 12th week after treatment
Drug: Amitriptyline
Amitriptyline will be used for prophylaxis of migraine, also used as antidepressant
Other Names:
  • Amyline
Experimental: Group B
Flunarizine group will be assessed at baseline and will be followed up at 6th week after treatment and at 12th week after treatment
Drug: Flunarizine 5mg
Flunarizine will be used for prophylaxis of migraine,
Other Names:
  • Sibelium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of headache
Time Frame: It will be asses at baseline, at 6th week, and at 12th week
pain severity will be assessed using Visual Analogue Scale (VAS)
It will be asses at baseline, at 6th week, and at 12th week
No. of Attacks per month
Time Frame: It will be asses at baseline, at 6th week, and at 12th week
reduction in number of attacks
It will be asses at baseline, at 6th week, and at 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalamar Institute of Health Sciences

Investigators

  • Study Director: Mujeeb-ur-Rehman Abid Butt, FCPS, Shalamar Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R&ID003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Over all results will be presented in the form of publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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