Clinical trial NCT03712917: Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine
Official title: Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine: A Randomised Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Greater Occipital Nerve Block
Topiramate
Flunarizine
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Post treatment 4 weeks
measure: Attack Frequencies
timeFrame: Post treatment 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Resarch Hospital
Study officials:
References:
citation: 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.
citation: Baker C. Double-blind evaluation of flunarizine and placebo in the prophylactic treatment of migraine. Headache 1987; 27:288.
citation: 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.
citation: 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.