Migraine DisordersPhase 4GONNCT02578719
Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up
A Phase 4 study testing bupivacaine and saline in people with Migraine Disorders, run by Bozok University.
Trial summary
This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- bupivacaine and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic migraine headache according to International Headache Society Classification Criteria
- Patients who are not using any prophylacting agent
Who cannot join
- 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.
About this study
Official title: Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
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.
- Conditions
- Migraine Disorders
- Being tested
- bupivacaine, saline
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
Also called marcaine
marcaine %0.5 20 ml flacon
salineDrug
Also called %0.9 sodium chloride
%0.9 sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| drug: bupivacaine | Placebo comparator | 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. Receives: Drug: bupivacaine |
| placebo | Placebo comparator | 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. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% decrease in migraine severity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Local Drug Authority didn't give permission to start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent E. Inan, Bozok University
- Investigators
- Levent E Inan, Prof., Principal investigator, Bozok University Neurology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578719
- Sponsor's protocol ID
- B.10.4.ISM.4.06.68.49/
- Acronym
- GON
- Status last verified
- Jan 2018
- First submitted
- 8 Oct 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
- ClinicalTrials.gov ID
- NCT02578719
- Acronym / sponsor ID
- GON / B.10.4.ISM.4.06.68.49/
- Conditions
- Migraine Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Local Drug Authority didn't give permission to start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug: bupivacaine | Placebo comparator | Drug: bupivacainePlacebo 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. |
| placebo | Placebo comparator | Drug: salinefirst 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic migraine headache according to International Headache Society Classification Criteria
- Patients who are not using any prophylacting agent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaineAlso: marcainemarcaine %0.5 20 ml flacon | Drug | drug: bupivacaine |
| salineAlso: %0.9 sodium chloride%0.9 sodium chloride | Drug | placebo |
Primary outcome
50% decrease in migraine severity
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 25765043Inan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Levent E Inan, Prof. principal investigator
Bozok University Neurology Department
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupivacaine and saline in people with Migraine Disorders, run by Bozok University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% decrease in migraine severity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02578719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.