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

NCT ID: NCT03712917

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-03-31

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Greater Occipital Nerve Block

Intervention Type: PROCEDURE

An enjection to paralyze the occipital nerve.

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.

Group Type: ACTIVE_COMPARATOR

Topiramate

Intervention Type: DRUG

An antiepileptic agent used for migraine prophylaxis.

Flunarizine

Flunarizine is introduced with a single dose of 10 mg/day.

Group Type: ACTIVE_COMPARATOR

Flunarizine

Intervention Type: DRUG

A calcium overload blocker agent used for migraine prophylaxis.

Interventions

Greater Occipital Nerve Block

An enjection to paralyze the occipital nerve.

Intervention Type: PROCEDURE

Topiramate

An antiepileptic agent used for migraine prophylaxis.

Intervention Type: DRUG

Flunarizine

A calcium overload blocker agent used for migraine prophylaxis.

Intervention Type: DRUG

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Ceylan

Principal İnvastigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University Resarch Hospital

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 15096395 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1454403 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019/22-3

Identifier Type: -

Identifier Source: org_study_id