- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04017741
A Study Investigating the Efficacy of GON Blocks.
A Phase IV Single Blind Placebo-controlled Cross Over Study to Investigate the Efficacy of Greater Occipital Nerve Block With Local Anesthetic and Steroid in Patients With Chronic Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic migraine is characterised by frequency of headache ≥ 15 days per month for more than 3 months. The location can be unilateral or bilateral. Usually described as pulsating in nature, it may be aggravated by, or cause avoidance of, routine activities of daily living. There can be associated light and noise sensitivity. Greater occipital nerve (GON) blockade with local anaesthetics and steroids has been used as a preventative strategy for a range of headaches including, migraine, cluster headache and hemicrania continua.
The occipital nerves have a sensory distribution in the occipital area. The greater occipital nerve derives most of its fibres from the C2 dorsal root [6]. It passes over the superior nuchal line, mid-way between the mastoid process and the occipital protuberance, just lateral to the insertion of the nuchal ligaments. The lesser occipital nerve passes lateral to the greater occipital nerve, over the nuchal ridge. Although the exact mechanism of action remains unclear, injection of steroid in the vicinity of GON nerve can have both a local effect (decreasing nociception) and a delayed central nociceptive response, possibly through an action on trigeminocervical relay
Although GON block is carried out extensively in the prophylaxis of chronic migraine, the evidence remains equivocal. In the UK, the National Institute for Clinical Excellence have yet to include GON blocks in their guidance and protocols on the treatment of both chronic headache and migraine. This randomised, single-blinded, placebo-controlled multicentre cross-over study intends to assess the efficacy, safety and tolerability of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine with the primary objective to investigate any improvement in disability associated with chronic migraine disorder. We also intend to identify any economic outcomes associated with these injections in the management of chronic migraine.
GON block with local anaesthetic and steroid for chronic migraine and the placebo procedure will be performed in the outpatient setting. They will be carried out only by appropriately qualified members of the research team adhering to strict aseptic conditions and following standard operating protocols with regards to admission and discharge criteria in the outpatient settings.
GON block is routinely carried out in the UK and poses minimal risks to the patient. Although GON block is carried out extensively in prophylaxis of chronic migraine, the evidence remains equivocal. In the UK, the National Institute for Health and Care Excellence (NICE) have yet to include GON blocks in their guidance and protocols on the treatment of both chronic headache and migraine.
The aim of this study is to assess the efficacy, safety and tolerability of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine of more than three months' duration.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, EC1A 4NP
- Barts Health NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active group
The active group will be administered 2 mls of 2% lidocaine and 80mg methylprednisolone.
|
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.
Other Names:
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.
Other Names:
|
Placebo Comparator: Placebo group
The placebo group will be administered 4mls of 0.9% saline.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The changes in disability associated with chronic migraine disorder at baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Headache frequency & Severity at baseline
Time Frame: baseline
|
changes in Frequency and severity as scored in the HIT-6 questionnaire.
Total scores can range between 36-78.
Scores higher than 60 can indicate more greater impact on patient life.
|
baseline
|
Change from baseline Headache frequency & Severity at 4 weeks
Time Frame: 4 weeks
|
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline.
Total scores can range between 36-78.
Scores higher than 60 can indicate more greater impact on patient life.
|
4 weeks
|
Change from baseline Headache frequency & Severity at 8 weeks
Time Frame: 8 weeks
|
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline.
Total scores can range between 36-78.
Scores higher than 60 can indicate more greater impact on patient life.
|
8 weeks
|
Change from baseline Headache frequency & Severity at 12 weeks
Time Frame: 12 weeks
|
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline.
Total scores can range between 36-78.
Scores higher than 60 can indicate more greater impact on patient life.
|
12 weeks
|
Change from baseline Headache frequency & Severity at 16 weeks
Time Frame: 16 weeks
|
changes in Frequency and severity as scored in the HIT-6 questionnaire.
Total scores can range between 36-78.
Scores higher than 60 can indicate more greater impact on patient life.
|
16 weeks
|
Change in Headache frequency & Severity at 20 weeks
Time Frame: 20 weeks
|
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline.Total scores can range between 36-78.
Scores higher than 60 can indicate more greater impact on patient life.
|
20 weeks
|
Change from baseline Headache frequency & Severity at 24 weeks
Time Frame: 24 weeks
|
changes in Frequency and severity as scored in the HIT-6 questionnaire.
Total scores can range between 36-78.
Scores higher than 60 can indicate more greater impact on patient life.
|
24 weeks
|
Change in anxiety and depression levels at baseline
Time Frame: baseline
|
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The higher the score, the more impact the headache has on the patient's life.
|
baseline
|
Change from baseline anxiety and depression levels at 4 weeks
Time Frame: 4 weeks
|
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The higher the score, the more impact the headache has on the patient's life.
|
4 weeks
|
Change from baseline anxiety and depression levels at 8 weeks
Time Frame: 8 weeks
|
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline
|
8 weeks
|
Change from baseline anxiety and depression levels at 12 weeks
Time Frame: 12 weeks
|
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The higher the score, the more impact the headache has on the patient's life.
|
12 weeks
|
Change from baseline anxiety and depression levels at 16 weeks
Time Frame: 16 weeks
|
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The higher the score, the more impact the headache has on the patient's life.
|
16 weeks
|
Change from baseline anxiety and depression levels at 20 weeks
Time Frame: 20 weeks
|
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The higher the score, the more impact the headache has on the patient's life.
|
20 weeks
|
Change from baseline anxiety and depression levels at 24 weeks
Time Frame: 24 weeks
|
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The higher the score, the more impact the headache has on the patient's life.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anish Bahra, University College London Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Headache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Lidocaine
Other Study ID Numbers
- 009665 BLT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Combined Depo-Medrone and Lidocaine
-
Mid and South Essex NHS Foundation TrustUniversity of East Anglia; National Institute for Health Research, United Kingdom and other collaboratorsCompletedChronic Kidney Diseases | GoutUnited Kingdom
-
Dundee Podiatry ClinicQueen Margaret UniversityCompleted
-
Keele UniversityArthritis Research UKCompletedCarpal Tunnel Syndrome (CTS)United Kingdom
-
Sohag UniversityNot yet recruiting
-
FHI 360Completed
-
Eunice Kennedy Shriver National Institute of Child...TerminatedChlamydia Infection | Neisseriaceae Infection
-
Assiut UniversityCompleted
-
IRCCS Burlo GarofoloCompletedProcedural Pain ReliefItaly
-
Augusta UniversityRecruiting