Efficacy of Flunarizine Vs Amitriptyline in Prophylaxis of Migraine Prophylaxis

NCT06162819 | Unknown DMC

• 1 other identifier: R&ID003
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine; Prophylaxis

Outcome Measures

Primary Outcomes (2)

• Severity of headache

  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

  reduction in number of attacks

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

Study Arms (2)

GroupA

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

Amitriptyline DRUG

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

Also known as: Amyline

GroupA

Flunarizine 5mg DRUG

Flunarizine will be used for prophylaxis of migraine,

Also known as: Sibelium

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalamar Institute of Health Sciences: lead

Study Sites (1)

Shalamar Hospital

Lahore, Punjab Province, 54840, Pakistan

Location

Related Publications (4)

• Gorur K, Gur H, Ismi O, Ozcan C, Vayisoglu Y. The effectiveness of propranolol, flunarizine, amitriptyline and botulinum toxin in vestibular migraine complaints and prophylaxis: a non-randomized controlled study. Braz J Otorhinolaryngol. 2022 Nov-Dec;88(6):975-981. doi: 10.1016/j.bjorl.2021.02.005. Epub 2021 Mar 7.

  PMID: 33722518 BACKGROUND

• Athar F, Zahid A, Farooq M, Ayyan M, Ashraf M, Farooq M, Naeem F, Badar A, Ehsan M, Hussain A, Ilyas MA. Frequency of migraine according to the ICHD-3 criteria and its association with sociodemographic and triggering factors in Pakistan: A cross-sectional study. Ann Med Surg (Lond). 2022 Sep 17;82:104589. doi: 10.1016/j.amsu.2022.104589. eCollection 2022 Oct.

  PMID: 36268304 RESULT

• Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.

  PMID: 35281991 RESULT

• Bendtsen L, Sacco S, Ashina M, Mitsikostas D, Ahmed F, Pozo-Rosich P, Martelletti P. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation. J Headache Pain. 2018 Sep 26;19(1):91. doi: 10.1186/s10194-018-0921-8.

  PMID: 30259200 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Amitriptyline; Flunarizine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mujeeb-ur-Rehman Abid Butt, FCPS

  Shalamar Institute of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Mahpara Nawazish, MBBS

CONTACT

+923060657757; mahpararajpoot123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients with migraine with even No. Medical Record will be assigned Amitriptyline whereas subjects with Odd Medical record No. will be treated with Flunarizine
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind, Randomized Parallel study design, All the consented participants will be randomized into two equal groups

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)