Back to resultsGreater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up (GON)
Primary Purpose
Migraine Disorders
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bupivacaine
saline
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Disorders
Eligibility Criteria
Inclusion Criteria:
- Chronic migraine headache according to International Headache Society Classification Criteria
- Patients who are not using any prophylacting agent
Exclusion Criteria:
- patients given similar treatments before
- pregnant women
- hereditary diseases causing bleeding
- patients who have intracranial tumor or operation in posterior fossa
- allergic reactions to local anesthetics.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
drug: bupivacaine
placebo
Arm Description
Placebo comparator: bupivacaine first 3 months 0.5% 1 cc bupivacaine diluated with 1.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
first 3 months 2.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
Outcomes
Primary Outcome Measures
50% decrease in migraine severity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02578719
Brief Title
Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up
Acronym
GON
Official Title
Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Local Drug Authority didn't give permission to start.
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozok University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.
Detailed Description
The greater occipital nerve (GON), which derives most of its fibers from the C2 dorsal root, is the primary sensory nerve of the occipital region. The response to GON blockade was not simply dependent on the direct local anesthetic effect of the injection . The mechanism of action might have been via changes in brain nociceptive pathways. Another possible explanation for these findings is, therefore, that GON injections initiated diffuse noxious inhibitory controls, independent of anesthetic effect . Neurophysiological and clinical data suggest there is a functional connection between the sensory occipital segments and the trigeminal nociceptive system in humans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
drug: bupivacaine
Arm Type
Placebo Comparator
Arm Description
Placebo comparator: bupivacaine first 3 months 0.5% 1 cc bupivacaine diluated with 1.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
first 3 months 2.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
marcaine %0.5 20 ml flacon
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
%0.9 sodium chloride
Intervention Description
%0.9 sodium chloride
Primary Outcome Measure Information:
Title
50% decrease in migraine severity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic migraine headache according to International Headache Society Classification Criteria
Patients who are not using any prophylacting agent
Exclusion Criteria:
patients given similar treatments before
pregnant women
hereditary diseases causing bleeding
patients who have intracranial tumor or operation in posterior fossa
allergic reactions to local anesthetics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent E Inan, Prof.
Organizational Affiliation
Bozok University Neurology Department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25765043
Citation
Inan LE, Inan N, Karadas O, Gul HL, Erdemoglu AK, Turkel Y, Akyol A. Greater occipital nerve blockade for the treatment of chronic migraine: a randomized, multicenter, double-blind, and placebo-controlled study. Acta Neurol Scand. 2015 Oct;132(4):270-7. doi: 10.1111/ane.12393. Epub 2015 Mar 13.
Results Reference
background
Learn more about this trial
Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up
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