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Completed

NCT Number: NCT03712917

Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine

Background: Preventive drug therapy in migraine aims to reduce the attack frequency, severity and duration of headache. Flunarizine and topiramate are widely used in the prevention of migraine attacks. Greater occipital nerve block (GONB) is an alternative treatment option for the prophylactic treatment of migraine. In this study, investigators compared the effectiveness of GONB, topiramate, and flunarizine in terms of reduction in post-treatment VAS scores and attack frequencies in patients with episodic migraine in a four-week period.

Material and Methods: At least one hundred and twenty migraine patients are aimed to be randomly divided into three treatment groups, namely flunarizine (n=40, estimated), topiramate (n=40, estimated) and GONB (n=40, estimated). The patients will be followed up for four weeks and the attack frequencies and VAS scores will be recorded weekly. At the end of the fourth week, the response rates based on 50% and 75% or more reduction in the VAS scores and attack frequencies will be calculated. Group-wise comparisons will be assessed statistically.

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Key information

Conditions

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

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Resarch Hospital

Erzurum, 25000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Migraine diagnosis according to ICHD-2
  • Ages between 15 -45 Volunteering
  • Monthly attack number between 5-14
  • BMI between 18-30
  • w/o history of nephrolithiasis
  • w/o history of DM, peripheral vascular disease
  • w/o history of chronic systemic diseases (lung, heart,liver, kidney)
  • w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
  • w/o history of acute or chronic psychiatric disease
  • w/o history of antiplatelet and anticoagulant medication
  • w/o any combination of medication overuse headache or other primary headaches
  • w/o previous medication of flunarizine and topiramate
  • w/o previous application of GONB

Exclusion criteria

  • Pregnancy
  • Lost to follow up
  • exited with his/her own will
  • detected primary headache during follow up
  • cessation due to adverse effects of topiramate
  • cessation due to adverse effects of flunarizine

Treatment and study plan

Greater occipital nerve block

Procedure

An enjection to paralyze the occipital nerve.

Topiramate

Drug

An antiepileptic agent used for migraine prophylaxis.

flunarizine

Drug

A calcium overload blocker agent used for migraine prophylaxis.

Primary outcomes

  1. Visual Analog Scale

    Time frame: Post treatment 4 weeks

    Range Pain 0-10, 0: No pain, 10: Worst Pain

  2. Attack Frequencies

    Time frame: Post treatment 4 weeks

    Number of headaches patients suffer in a month.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine: A Randomised Parallel Group Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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