A study to investigate the effectiveness of performing a nerve block on patients suffering from chronic migraines.

A phase IV single-blind placebo-controlled cross-over study to investigate the efficacy of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine. - GON migraine study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001115-39-GB

Enrollment

Registered

2015-09-11

Start date

2015-12-29

Completion date

Unknown

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic migraine MedDRA version: 18.0 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852

Interventions

Trade Name: Lidocaine 2% Product Name: 2% Lidocaine Product Code: N/A Pharmaceutical Form: Injection INN or Proposed INN: Lidocaine CAS Number: 137-58-6 Concentration unit: mg/ml milligram(s)/millilit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age over 18 and ability to provide written consent. 2.Diagnosis of chronic migraine with or without acute relief medication overuse (ICHD-II codes 1.5.1 and 1.6.5); as confirmed by diary documentation (headache on 15 or more days a month for at least 3 months). 3.Ability to read and write English (questionnaire use in the study) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1.Patient refusal. 2.Participation in another trial of any investigational products or interventional research project within the previous 8 weeks. 3.Patients unable to commit to the 6-month study duration. 4.Patients with known hypersensitivity to the investigational medicinal products used in the study. 5.Patients with a history of substance abuse. 6.Pregnant or breastfeeding patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study, is to investigate any change in disability associated with chronic migraine disorder in the two treatment arms (greater occipital nerve block versus placebo procedure). ;Secondary Objective: a. To assess change in participant headache frequency and severity, b. To assess the change in participant anxiety and depression levels, c. To assess the safety and tolerability in the two treatment arms. d. To assess the eligibility criteria, recruitment and retention of participants in the two treatment arms. e. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams. ;Primary end point(s): The primary outcome being measured in this study is improvement in disability associated with chronic migraine disorder as assessed by: • Change in the Headache Impact Test (HIT-6) questionnaire score • Change in the Migraine-Specific Questionnaire (MSQ) score • Change in the 12-item Short Form Health Survey (SF-12) questionnaire score;Timepoint(s) of evaluation of this end point: Baseline 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). Cross over 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).	—

Measure

Time frame

Main Objective: The primary objective of this study, is to investigate any change in disability associated with chronic migraine disorder in the two treatment arms (greater occipital nerve block versus placebo procedure). ;Secondary Objective: a. To assess change in participant headache frequency and severity, b. To assess the change in participant anxiety and depression levels, c. To assess the safety and tolerability in the two treatment arms. d. To assess the eligibility criteria, recruitment and retention of participants in the two treatment arms. e. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams. ;Primary end point(s): The primary outcome being measured in this study is improvement in disability associated with chronic migraine disorder as assessed by: • Change in the Headache Impact Test (HIT-6) questionnaire score • Change in the Migraine-Specific Questionnaire (MSQ) score • Change in the 12-item Short Form Health Survey (SF-12) questionnaire score;Timepoint(s) of evaluation of this end point: Baseline 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). Cross over 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).

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Secondary

Measure	Time frame
Secondary end point(s): The secondary objectives are to assess: a. change in headache characteristics: frequency & severity (HIT-6 score) b. change in anxiety and depression (HAD scores) c. safety of intervention (SAR/SAE reports) d. tolerability (SAR/SAE reports) e. economic outcomes f. eligibility criteria, recruitment and retention of patients in the two treatment arms (recruitment and retention rates). g. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams (questionnaire upon completion of study and feedback from clinicians regarding overall feasibility/acceptability of the two treatment arms). ;Timepoint(s) of evaluation of this end point: Baseline 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). Cross over 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).	—

Measure

Time frame

Secondary end point(s): The secondary objectives are to assess: a. change in headache characteristics: frequency & severity (HIT-6 score) b. change in anxiety and depression (HAD scores) c. safety of intervention (SAR/SAE reports) d. tolerability (SAR/SAE reports) e. economic outcomes f. eligibility criteria, recruitment and retention of patients in the two treatment arms (recruitment and retention rates). g. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams (questionnaire upon completion of study and feedback from clinicians regarding overall feasibility/acceptability of the two treatment arms). ;Timepoint(s) of evaluation of this end point: Baseline 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). Cross over 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).

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Countries

United Kingdom

Contacts

Public ContactSally Burtles

Barts Health NHS Trust

sponsorsrep@bartshealth.nhs.uk02078827250

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026