NCT04017741

Brief Summary

Greater occipital nerve block ("GON block") is carried out extensively in the treatment of chronic migraine, but more research is required to understand the effectiveness of the procedure. It consists of a superficial injection of local anaesthetic and steroid around a nerve at the back of the head that supplies sensation to part of the scalp. This study intends to provide more detailed information on the effectiveness, safety and tolerability of GON block with local anaesthetic and steroid in patients with chronic migraine. It does this by comparing it to a dummy (placebo) procedure (a needle is inserted near the nerve, but no therapeutic substance is injected). It is a "cross-over study": all patients will receive both the GON block and the dummy procedure (not necessarily in that order), with a period in between to assess the response to the first injection. The GON block will entail an injection of 2 mls of 2% lidocaine (a local anaesthetic) and 80 mg of DepoMedrone (a steroid) through a fine needle (a total of 4 mls). The dummy procedure will consist of an injection of 4 mls of normal saline (a solution of common salt and water) through a fine needle. Patients will be followed up at various time points throughout 6 months whilst being enrolled on the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

March 27, 2020

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

April 16, 2019

Last Update Submit

March 26, 2020

Conditions

MigraineChronic Migraine, Headache

Keywords

Chronic migraine, GON blocks

Outcome Measures

Primary Outcomes (21)

  • The changes in disability associated with chronic migraine disorder at baseline

    The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.

    Baseline

  • The changes in baseline headache impact test scores (HIT-6) at 4 weeks

    The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.

    4 weeks

  • The changes in baseline headache impact test scores (HIT-6) at 8 weeks

    The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.

    8 weeks

  • The changes in baseline headache impact test scores (HIT-6) at 12 weeks

    The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.

    12 weeks

  • The changes in baseline headache impact test scores (HIT-6) at 16 weeks

    The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.

    16 weeks

  • The changes in baseline headache impact test scores (HIT-6) at 20 weeks

    The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.

    20 weeks

  • The changes in baseline headache impact test scores (HIT-6) at 24 weeks

    The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.

    24 weeks

  • change in quality of life relating to migraine at baseline

    average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.

    baseline

  • change in quality of life relating to migraine from baseline at 4 weeks

    average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.

    4 weeks

  • change in quality of life relating to migraine from baseline at 8 weeks

    average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.

    8 weeks

  • change in quality of life relating to migraine from baseline at 12 weeks

    average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.

    12 weeks

  • change in quality of life relating to migraine from baseline at 16 weeks

    average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.

    16 weeks

  • change in quality of life relating to migraine from baseline at 20 weeks

    average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.

    20 weeks

  • change in quality of life relating to migraine from baseline at 24 weeks

    average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.

    24 weeks

  • change in health related quality of life associated with chronic migraine disorder at baseline

    The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.

    baseline

  • change in health related quality of life associated with chronic migraine disorder from baseline at 4 weeks

    The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.

    4 weeks

  • change in health related quality of life associated with chronic migraine disorder from baseline at 8 weeks

    The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.

    8 weeks

  • change in health related quality of life associated with chronic migraine disorder from baseline at 12 weeks

    The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.

    12 weeks

  • change in health related quality of life associated with chronic migraine disorder from baseline at 16 weeks

    The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.

    16 weeks

  • change in health related quality of life associated with chronic migraine disorder from baseline at 20 weeks

    The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.

    20 weeks

  • change in health related quality of life associated with chronic migraine disorder from baseline at 24 weeks

    The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.

    24 weeks

Secondary Outcomes (14)

  • Change in Headache frequency & Severity at baseline

    baseline

  • Change from baseline Headache frequency & Severity at 4 weeks

    4 weeks

  • Change from baseline Headache frequency & Severity at 8 weeks

    8 weeks

  • Change from baseline Headache frequency & Severity at 12 weeks

    12 weeks

  • Change from baseline Headache frequency & Severity at 16 weeks

    16 weeks

  • +9 more secondary outcomes

Study Arms (2)

Active group

ACTIVE COMPARATOR

The active group will be administered 2 mls of 2% lidocaine and 80mg methylprednisolone.

Drug: Combined Depo-Medrone and LidocaineDrug: Sodium Chloride 0.9% Inj

Placebo group

PLACEBO COMPARATOR

The placebo group will be administered 4mls of 0.9% saline.

Drug: Combined Depo-Medrone and LidocaineDrug: Sodium Chloride 0.9% Inj

Interventions

Combined Depo-Medrone and LidocaineDRUG

Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle, the IMPs are injected at a 90 degrees angle till the bony endpoint is obtained. A combination of 2 mls of 2% lidocaine and 80mg methylprednisolone will be administered. Patients who no longer receive any benefit will be crossed over to the placebo arm.

Also known as: Methylprednisolone Acetate BP 40mg/mL:, Lidocaine Hydrochloride 2%:
Active groupPlacebo group
Sodium Chloride 0.9% InjDRUG

Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle the 4mls of normal saline (0.9%) are injected at a 90 degrees angle till the bony endpoint is obtained. Patients who no longer receive any benefit will be crossed over to the active arm.

Also known as: normal saline 0.9%
Active groupPlacebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged over the age of 18 who are able to provide a written consent
  • Ability to read and write English, due to questionnaire use in study
  • Diagnosis of chronic migraine with or without acute relief medication overuse (ICHD-III codes 1.3 and 8.2); as confirmed by diary documentation (headache on 15 or more days a month for at least 3 months)

You may not qualify if:

  • Patient refusal
  • Participation in any trial of any investigational products or interventional research project within the previous eight weeks to enrolment
  • Patients unable to commit to the six-month study duration (PI judgment)
  • Any known contraindication(s) to the IMPs as described by the manufacturer's Summary of Product Characteristics (SmPCs)
  • Patients with a history of substance abuse
  • Pregnant or breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, EC1A 4NP, United Kingdom

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

LidocaineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Anish Bahra

    University College London Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This is a blinded, placebo controlled study, whereby the patient and the research team except for the injector are blinded.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Consented participants will be individually randomised by the Principal Investigator (PI) in a 1:1 ratio to receive either the GON block (active group) or the placebo injection (control group).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

July 12, 2019

Study Start

February 14, 2018

Primary Completion

December 31, 2019

Study Completion

January 23, 2020

Last Updated

March 27, 2020

Record last verified: 2019-11

Locations

GB(1)