Migraine
Conditions
Keywords
Migraine, Greater Occipital Nerve Block, Topiramate, Flunarizine
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.
Interventions
PROCEDUREGreater Occipital Nerve Block
An enjection to paralyze the occipital nerve.
DRUGTopiramate
An antiepileptic agent used for migraine prophylaxis.
DRUGFlunarizine
A calcium overload blocker agent used for migraine prophylaxis.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | Post treatment 4 weeks | Range Pain 0-10, 0: No pain, 10: Worst Pain |
| Attack Frequencies | Post treatment 4 weeks | Number of headaches patients suffer in a month. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve. | 40 |
| 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.
Topiramate: An antiepileptic agent used for migraine prophylaxis. | 40 |
| Flunarizine Flunarizine is introduced with a single dose of 10 mg/day.
Flunarizine: A calcium overload blocker agent used for migraine prophylaxis. | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 | 3 |
| Overall Study | Lost to Follow-up | 9 | 4 | 5 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Greater Occipital Nerve Block | Topiramate | Flunarizine | Total |
|---|---|---|---|---|
| Age, Continuous | 30.2 years STANDARD_DEVIATION 8.9 | 31.5 years STANDARD_DEVIATION 8.2 | 30.9 years STANDARD_DEVIATION 9 | 30.9 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 40 Participants | 40 Participants | 120 Participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 24 Participants | 72 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 4 / 40 | 3 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Attack Frequencies
Number of headaches patients suffer in a month.
Time frame: Post treatment 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve Block | Attack Frequencies | Pretreatment | 8.6 headaches per month | Standard Deviation 2.6 |
| Greater Occipital Nerve Block | Attack Frequencies | Posttreatment | 3.3 headaches per month | Standard Deviation 1 |
| Topiramate | Attack Frequencies | Pretreatment | 8.0 headaches per month | Standard Deviation 2.7 |
| Topiramate | Attack Frequencies | Posttreatment | 2.7 headaches per month | Standard Deviation 2.3 |
| Flunarizine | Attack Frequencies | Pretreatment | 8.0 headaches per month | Standard Deviation 2.4 |
| Flunarizine | Attack Frequencies | Posttreatment | 2.8 headaches per month | Standard Deviation 1.4 |
Primary
Visual Analog Scale
Range Pain 0-10, 0: No pain, 10: Worst Pain
Time frame: Post treatment 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Greater Occipital Nerve Block | Visual Analog Scale | Pretreatment | 8.1 score on a scale | Standard Deviation 1 |
| Greater Occipital Nerve Block | Visual Analog Scale | Posttreatment | 5.9 score on a scale | Standard Deviation 1.6 |
| Topiramate | Visual Analog Scale | Pretreatment | 7.9 score on a scale | Standard Deviation 0.9 |
| Topiramate | Visual Analog Scale | Posttreatment | 5.5 score on a scale | Standard Deviation 2.1 |
| Flunarizine | Visual Analog Scale | Pretreatment | 7.9 score on a scale | Standard Deviation 0.9 |
| Flunarizine | Visual Analog Scale | Posttreatment | 5.3 score on a scale | Standard Deviation 1.7 |