NCT03712917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 21, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

October 13, 2018

Results QC Date

November 24, 2019

Last Update Submit

January 11, 2020

Conditions

Migraine

Keywords

MigraineGreater Occipital Nerve BlockTopiramateFlunarizine

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Greater Occipital Nerve Block

ACTIVE COMPARATOR

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

Topiramate

ACTIVE COMPARATOR

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

Flunarizine

ACTIVE COMPARATOR

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

Drug: Flunarizine

Interventions

Greater Occipital Nerve BlockPROCEDURE

An enjection to paralyze the occipital nerve.

Greater Occipital Nerve Block
TopiramateDRUG

An antiepileptic agent used for migraine prophylaxis.

Topiramate
FlunarizineDRUG

A calcium overload blocker agent used for migraine prophylaxis.

Flunarizine

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Resarch Hospital

Erzurum, 25000, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    BACKGROUND

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

    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.

    PMID: 15096395BACKGROUND

  • 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.

    PMID: 1454403BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

TopiramateFlunarizine

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetosesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Mustafa Ceylan
Organization
Ataturk University
drmuson16@hotmail.com
+905062773216

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvastigator

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 19, 2018

Study Start

March 1, 2019

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

January 21, 2020

Results First Posted

January 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)