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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Flunarizine | Active Comparator | Flunarizine is introduced with a single dose of 10 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Greater Occipital Nerve Block | Procedure | An enjection to paralyze the occipital nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
Lost to follow up
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University Resarch Hospital | Erzurum | 25000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 15096395 | 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. | |
| 1454403 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Flunarizine | Flunarizine is introduced with a single dose of 10 mg/day. Flunarizine: A calcium overload blocker agent used for migraine prophylaxis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Row population is the defined after the exclusion of patients from overall study population |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale | Range Pain 0-10, 0: No pain, 10: Worst Pain | Posted | Mean | Standard Deviation | score on a scale | Post treatment 4 weeks |
|
From the start of the study till the end (one month)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | Non-systematic Assessment | Mild daytime sedation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Ceylan | Ataturk University | +905062773216 | drmuson16@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2019 | Dec 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| D005444 | Flunarizine |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Topiramate | Drug | An antiepileptic agent used for migraine prophylaxis. |
|
| Flunarizine | Drug | A calcium overload blocker agent used for migraine prophylaxis. |
|
| Background |
| 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. |
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Flunarizine | Flunarizine is introduced with a single dose of 10 mg/day. Flunarizine: A calcium overload blocker agent used for migraine prophylaxis. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Row population is the defined after the exclusion of patients from overall study population | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
| OG002 | Flunarizine | Flunarizine is introduced with a single dose of 10 mg/day. Flunarizine: A calcium overload blocker agent used for migraine prophylaxis. |
|
|
| Primary | Attack Frequencies | Number of headaches patients suffer in a month. | Posted | Mean | Standard Deviation | headaches per month | Post treatment 4 weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 40 | 0 | 40 | 4 | 40 |
| EG002 | Flunarizine | Flunarizine is introduced with a single dose of 10 mg/day. Flunarizine: A calcium overload blocker agent used for migraine prophylaxis. | 0 | 40 | 0 | 40 | 3 | 40 |
| Fatique | Nervous system disorders | Non-systematic Assessment |
|
| paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| memory difficulties | Nervous system disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| Carbohydrates |
| D007661 | Ketoses |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|