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

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ClinicalTrials.gov Identifier: NCT03712917
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Mustafa Ceylan, Ataturk University

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.


Condition or disease Intervention/treatment Phase
Migraine Procedure: Greater Occipital Nerve Block Drug: Topiramate Drug: Flunarizine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine: A Randomised Parallel Group Study
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Topiramate

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.




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 4 weeks ]
    Range Pain 0-10, 0: No pain, 10: Worst Pain

  2. Attack frequencies [ Time Frame: 4 weeks ]
    Number of headaches patients suffer in a month.



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712917


Locations
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Turkey
Ataturk University Resarch Hospital
Erzurum, Turkey, 25000
Sponsors and Collaborators
Ataturk University

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.

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Responsible Party: Mustafa Ceylan, Principal İnvastigator, Ataturk University
ClinicalTrials.gov Identifier: NCT03712917     History of Changes
Other Study ID Numbers: 2019/22-3
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mustafa Ceylan, Ataturk University:
Migraine
Greater Occipital Nerve Block
Topiramate
Flunarizine

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Flunarizine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Vasodilator Agents