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

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Procedure: Greater Occipital Nerve Block; Drug: Topiramate; Drug: Flunarizine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25000
    • Ataturk University Resarch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy

2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Greater Occipital Nerve Block; The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.	Procedure: Greater Occipital Nerve Block; An enjection to paralyze the occipital nerve.
Active Comparator: Topiramate; Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.	Drug: Topiramate; An antiepileptic agent used for migraine prophylaxis.
Active Comparator: Flunarizine; Flunarizine is introduced with a single dose of 10 mg/day.	Drug: Flunarizine; A calcium overload blocker agent used for migraine prophylaxis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Range Pain 0-10, 0: No pain, 10: Worst Pain	Post treatment 4 weeks
Attack Frequencies	Number of headaches patients suffer in a month.	Post treatment 4 weeks

Collaborators and Investigators

• Sponsor: Ataturk University

Publications and helpful links

General Publications

• Diener H-C, Goadsby PJ. Migraine In: Brandt T, Caplan L, Dichgans J, Diener H-C, Kennard C (eds) Course and treatment of neurological disorders. 2nd edition. Academic Press, San Diego, (2003). pp 1-16.
• Baker C. Double-blind evaluation of flunarizine and placebo in the prophylactic treatment of migraine. Headache 1987; 27:288.
• Silberstein SD, Neto W, Schmitt J, Jacobs D; MIGR-001 Study Group. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004 Apr;61(4):490-5. doi: 10.1001/archneur.61.4.490.
• Bovim G, Sand T. Cervicogenic headache, migraine without aura and tension-type headache. Diagnostic blockade of greater occipital and supra-orbital nerves. Pain. 1992 Oct;51(1):43-48. doi: 10.1016/0304-3959(92)90007-X.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: October 13, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 11, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Migraine; Topiramate; Greater Occipital Nerve Block; Flunarizine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Flunarizine; Topiramate
• Other Study ID Numbers: 2019/22-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No