Repetitive GON Blockade for Menstrual Migraine

NCT07576309 | Completed

• 1 other identifier: E66291034-202.3.02-5953
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Menstrual Migraine; Menstrually Related Migraine

Keywords

Menstrual Migraine; Greater Occipital Nerve Block; GON Blockade; Bupivacaine; Migraine Prophylaxis; Peripheral Neuromodulation; Perimenstrual Period

Outcome Measures

Primary Outcomes (1)

• Change in headache severity evaluated using the Visual Analog Scale (VAS)

  Headache severity measured by VAS.

  Baseline, Month 3, and Month 6

Secondary Outcomes (5)

• Change in monthly migraine attack frequency

  Baseline, Month 3, and Month 6

• Change in number of headache days per month

  Baseline, Month 3, and Month 6

• Change in mean attack duration in hours

  Baseline, Month 3, and Month 6

• Change in monthly analgesic consumption

  Baseline, Month 3, and Month 6

• Change in Migraine Disability Assessment (MIDAS) scores

  Baseline, Month 3, and Month 6

Study Arms (2)

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).

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.

Other: Normal Saline

Interventions

0.5% bupivacaine DRUG

Bilateral greater occipital nerve (GON) blockade using a local anesthetic.

Active Treatment: 0.5% Bupivacaine

Normal Saline OTHER

Bilateral greater occipital nerve (GON) blockade using placebo (normal saline).

Placebo: Normal Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39948478 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treatment allocation was known only to the investigational pharmacist and the study coordinator; the patients, administering physicians, and outcome assessors were kept blind throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, MD

Model Details: Randomization was planned using a Latin square experimental design to balance the distribution of active treatment and placebo.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 8, 2026
• Study Start: October 19, 2024
• Primary Completion: May 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available immediately following the publication of the study results and will remain accessible indefinitely.
• Access Criteria: De-identified individual participant data that underlie the results reported in this article will be shared. Data will be available to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Requests should be directed to the corresponding author via email. Access may require signing a data access agreement.

Locations

TU (1)