N/A
Completed N=120
Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine
Source: ClinicalTrials.gov NCT03712917 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Visual Analog Scale — 8.1; 7.9; 7.9; 5.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale |
8.1; 7.9; 7.9; 5.9; 5.5; 5.3 | — |
| PRIMARY Attack Frequencies |
8.6; 8.0; 8.0; 3.3; 2.7; 2.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03712917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.