Menstrual MigraineNCT07576309
Repetitive GON Blockade for Menstrual Migraine
A study testing 0.5% bupivacaine and Normal Saline in people with Menstrual Migraine and Menstrually Related Migraine, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
: The primary objective of this prospective, randomized, double-blind, placebo-controlled clinical trial is to evaluate whether repetitive bilateral greater occipital nerve (GON) blockade administered with a local anesthetic (0.5% bupivacaine) significantly reduces headache severity, attack duration, and the number of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Menstrual Migraine, Menstrually Related Migraine
- What is being tested?
- 0.5% bupivacaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2024to 30 Nov 2025
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with pure menstrual migraine or menstrually related migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria.
- A documented history of migraine attacks during the perimenstrual period (between days -2 and +3 relative to the onset of menstruation) in at least two of the last three menstrual cycles.
Who cannot join
- Diagnosis of chronic migraine.
- Presence of an additional primary or secondary headache disorder.
- Pregnant or lactating.
- Known hypersensitivity to local anesthetics.
- Received an occipital nerve blockade within the last three months.
- Presence of a significant neurological or systemic disease that could affect the outcome evaluation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi
Istanbul, Istanbul, 34668
About this study
Official title: Perimenstrual Repetitive Greater Occipital Nerve Blockade for Menstrual Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
: The primary objective of this prospective, randomized, double-blind, placebo-controlled clinical trial is to evaluate whether repetitive bilateral greater occipital nerve (GON) blockade administered with a local anesthetic (0.5% bupivacaine) significantly reduces headache severity, attack duration, and the number of pain days in female patients with menstrual migraine compared to a placebo group (normal saline). Patients will receive injections twice a month for three months (seven days before the expected onset of menstruation and on the first day of menstruation).
Read the detailed description
Menstrual migraine (MM) is a highly prevalent and challenging migraine subtype triggered by fluctuations in estrogen and progesterone levels, particularly estrogen withdrawal during the perimenstrual period
- This hormonal withdrawal sensitizes the trigeminovascular system and promotes the release of neuropeptides such as calcitonin gene-related peptide (CGRP)
- Currently, there are no licensed prophylactic medications specifically developed for MM, making alternative and non-systemic treatments necessary
This study investigates the efficacy of a targeted peripheral neuromodulation approach using bilateral greater occipital nerve (GON) blockade. The underlying clinical rationale is that GON blockade timed to the perimenstrual period can modulate nociceptive transmission at the trigeminocervical complex (TCC) and decrease peripheral nerve excitability, thereby limiting the impact of cyclic hormonal fluctuations on the trigeminovascular system
. In this trial, a Latin square experimental design is utilized to ensure balanced randomization between the active treatment and placebo groups
- Unlike single-injection protocols, the intervention is specifically synchronized with the patients' menstrual cycles, involving injections twice a month over a three-month period (seven days before menstruation and on the first day of menstruation)
- By evaluating this specific timing and repetitive protocol, the study aims to establish whether perimenstrual-targeted GON blockade can serve as an effective, non-systemic, short-term prophylactic strategy for patients suffering from this refractory migraine subtype.
- Conditions
- Menstrual Migraine, Menstrually Related Migraine
- Being tested
- 0.5% bupivacaine, Normal Saline
- Keywords
- Menstrual Migraine, Greater Occipital Nerve Block, GON Blockade, Bupivacaine, Migraine Prophylaxis, Peripheral Neuromodulation, Perimenstrual Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% bupivacaineDrug
Bilateral greater occipital nerve (GON) blockade using a local anesthetic.
Normal SalineOther
Bilateral greater occipital nerve (GON) blockade using placebo (normal saline).
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment: 0.5% Bupivacaine | Experimental | Patients receive bilateral greater occipital nerve (GON) blockade using 0.5% bupivacaine. Injections are administered twice a month for three months (seven days before the expected onset of menstruation and on the first day of menstruation). Receives: Drug: 0.5% bupivacaine |
| Placebo: Normal Saline | Placebo comparator | Patients receive bilateral greater occipital nerve (GON) blockade using an equivalent volume of normal saline. Injections are administered twice a month for three months, following the same schedule as the active treatment group. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache severity evaluated using the Visual Analog Scale (VAS)
Headache severity measured by VAS.
Measured: Baseline, Month 3, and Month 6
Secondary outcomes (5)
Change in monthly migraine attack frequency
Measured: Baseline, Month 3, and Month 6
Change in number of headache days per month
Measured: Baseline, Month 3, and Month 6
Change in mean attack duration in hours
Measured: Baseline, Month 3, and Month 6
Change in monthly analgesic consumption
Measured: Baseline, Month 3, and Month 6
Change in Migraine Disability Assessment (MIDAS) scores
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start19 Oct 2024
- Primary completion30 May 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menstrual MigraineStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization was planned using a Latin square experimental design to balance the distribution of active treatment and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAZLI GAMZE BÜLBÜL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576309
- Sponsor's protocol ID
- E66291034-202.3.02-5953
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting the findings of this study is available from the corresponding author upon reasonable request.
Publications
Cetin G, Totuk O, Cetin OE, Demir S, Sahin S. Evaluation of the effectiveness of greater occipital nerve blockade in menstrual migraine. BMC Neurol. 2025 Feb 13;25(1):62. doi: 10.1186/s12883-025-04070-2.
PubMed 39948478Aksahin O, Bulbul NG, Ozdag MF. Perimenstrual repetitive greater occipital nerve blockade for menstrual migraine: a randomized, double-blind, placebo-controlled trial. BMC Neurol. 2026 Aug 18;26(1):668. doi: 10.1186/s12883-026-05238-0.
PubMed 42920151
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perimenstrual Repetitive Greater Occipital Nerve Blockade for Menstrual Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07576309
- Acronym / sponsor ID
- E66291034-202.3.02-5953
- Conditions
- Menstrual Migraine, Menstrually Related Migraine
- Keywords
- Menstrual Migraine, Greater Occipital Nerve Block, GON Blockade, Bupivacaine, Migraine Prophylaxis, Peripheral Neuromodulation, Perimenstrual Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 8 May 2026 (actual)
- 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.
: The primary objective of this prospective, randomized, double-blind, placebo-controlled clinical trial is to evaluate whether repetitive bilateral greater occipital nerve (GON) blockade administered with a local anesthetic (0.5% bupivacaine) significantly reduces headache severity, attack duration, and the number of pain days in female patients with menstrual migraine compared to a placebo group (normal saline). Patients will receive injections twice a month for three months (seven days before the expected onset of menstruation and on the first day of menstruation).
Detailed description
Menstrual migraine (MM) is a highly prevalent and challenging migraine subtype triggered by fluctuations in estrogen and progesterone levels, particularly estrogen withdrawal during the perimenstrual period
- This hormonal withdrawal sensitizes the trigeminovascular system and promotes the release of neuropeptides such as calcitonin gene-related peptide (CGRP)
- Currently, there are no licensed prophylactic medications specifically developed for MM, making alternative and non-systemic treatments necessary
This study investigates the efficacy of a targeted peripheral neuromodulation approach using bilateral greater occipital nerve (GON) blockade. The underlying clinical rationale is that GON blockade timed to the perimenstrual period can modulate nociceptive transmission at the trigeminocervical complex (TCC) and decrease peripheral nerve excitability, thereby limiting the impact of cyclic hormonal fluctuations on the trigeminovascular system
. In this trial, a Latin square experimental design is utilized to ensure balanced randomization between the active treatment and placebo groups
- Unlike single-injection protocols, the intervention is specifically synchronized with the patients' menstrual cycles, involving injections twice a month over a three-month period (seven days before menstruation and on the first day of menstruation)
- By evaluating this specific timing and repetitive protocol, the study aims to establish whether perimenstrual-targeted GON blockade can serve as an effective, non-systemic, short-term prophylactic strategy for patients suffering from this refractory migraine subtype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization was planned using a Latin square experimental design to balance the distribution of active treatment and placebo.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment: 0.5% Bupivacaine | Experimental | Drug: 0.5% bupivacainePatients receive bilateral greater occipital nerve (GON) blockade using 0.5% bupivacaine. Injections are administered twice a month for three months (seven days before the expected onset of menstruation and on the first day of menstruation). |
| Placebo: Normal Saline | Placebo comparator | Other: Normal SalinePatients receive bilateral greater occipital nerve (GON) blockade using an equivalent volume of normal saline. Injections are administered twice a month for three months, following the same schedule as the active treatment group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with pure menstrual migraine or menstrually related migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria.
- A documented history of migraine attacks during the perimenstrual period (between days -2 and +3 relative to the onset of menstruation) in at least two of the last three menstrual cycles.
Key exclusion criteria (6 listed)
- Diagnosis of chronic migraine.
- Presence of an additional primary or secondary headache disorder.
- Pregnant or lactating.
- Known hypersensitivity to local anesthetics.
- Received an occipital nerve blockade within the last three months.
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 |
|---|---|---|
| 0.5% bupivacaineBilateral greater occipital nerve (GON) blockade using a local anesthetic. | Drug | Active Treatment: 0.5% Bupivacaine |
| Normal SalineBilateral greater occipital nerve (GON) blockade using placebo (normal saline). | Other | Placebo: Normal Saline |
Primary outcome
Change in headache severity evaluated using the Visual Analog Scale (VAS)
Time frame: Baseline, Month 3, and Month 6
Headache severity measured by VAS.
5 secondary outcomes
Change in monthly migraine attack frequency
Time frame: Baseline, Month 3, and Month 6
Change in number of headache days per month
Time frame: Baseline, Month 3, and Month 6
Change in mean attack duration in hours
Time frame: Baseline, Month 3, and Month 6
Change in monthly analgesic consumption
Time frame: Baseline, Month 3, and Month 6
Change in Migraine Disability Assessment (MIDAS) scores
Time frame: Baseline, Month 3, and Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 39948478Cetin G, Totuk O, Cetin OE, Demir S, Sahin S. Evaluation of the effectiveness of greater occipital nerve blockade in menstrual migraine. BMC Neurol. 2025 Feb 13;25(1):62. doi: 10.1186/s12883-025-04070-2.
- Derived from this study: PubMed 42920151Aksahin O, Bulbul NG, Ozdag MF. Perimenstrual repetitive greater occipital nerve blockade for menstrual migraine: a randomized, double-blind, placebo-controlled trial. BMC Neurol. 2026 Aug 18;26(1):668. doi: 10.1186/s12883-026-05238-0.
- Individual participant dataSharing planned: Yes. The data supporting the findings of this study is available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5% bupivacaine and Normal Saline in people with Menstrual Migraine and Menstrually Related Migraine, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in headache severity evaluated using the Visual Analog Scale (VAS) (time frame: Baseline, Month 3, and Month 6). 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 NCT07576309, which also lists 2 linked publications.
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 8 May 2026.