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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712917
• Other study ID #: 2019/22-3
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 31, 2019

Study information

• Verified date: January 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Procedure:
• Greater Occipital Nerve Block
An enjection to paralyze the occipital nerve.

Drug:
• Topiramate
An antiepileptic agent used for migraine prophylaxis.
• Flunarizine
A calcium overload blocker agent used for migraine prophylaxis.

Locations

Country	Name	City	State
Turkey	Ataturk University Resarch Hospital	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Baker C. Double-blind evaluation of flunarizine and placebo in the prophylactic treatment of migraine. Headache 1987; 27:288.

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):43-8. — View 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.

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. — View Citation

Outcome

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