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WithdrawnNCT02578719GONUpdated Jan 23, 2018

Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up

A Phase 4 interventional study of bupivacaine and saline in Migraine Disorders, sponsored by Bozok University. Withdrawn. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Bozok University · Phase 4, Interventional, and Prevention

Why this study was withdrawn
Local Drug Authority didn't give permission to start.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.

Read the 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.

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Conditions studied

  • Migraine Disorders

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

Browse Migraine Disorders studies →

Lead sponsor

Bozok University is the lead sponsor of 53 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic migraine headache according to International Headache Society Classification Criteria
  • Patients who are not using any prophylacting agent

Exclusion criteria

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.
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    drug: bupivacaine

    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.

    Drug: bupivacaine

  • Placebo comparator
    placebo

    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.

    Drug: saline

Interventions

  • Drugbupivacaine

    marcaine %0.5 20 ml flacon

    Also known as: marcaine

  • Drugsaline

    %0.9 sodium chloride

    Also known as: %0.9 sodium chloride

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What researchers measure

Primary outcomes

  1. 50% decrease in migraine severity

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 25765043 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02578719
Lead sponsor
Bozok University
Responsible party
Levent E. Inan (Professor, Bozok University) — Principal investigator
First posted
Oct 19, 2015
Start date
Jul 2016
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Jan 23, 2018

Study contacts

Levent E Inan, Prof.
principal investigator · Bozok University Neurology Department

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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