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    Clinical Trial Results:
    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.

    Summary
    EudraCT number
    		 2014-001115-39
    Trial protocol
    		 GB  
    Global end of trial date
    23 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2021
    First version publication date
    19 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GON2014/05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Barts Health NHS Trust
    Sponsor organisation address
    Trust headquarters Executive Offices Ground Floor Pathology and Pharmacy Building, London, United Kingdom, E1 2ES
    Public contact
    Dr Vivek Mehta, Barts Health NHS Trust , +44 02034656010, vivek.mehta@nhs.net
    Scientific contact
    Dr Vivek Mehta , Barts Health NHS Trust, +44 02034656010, vivek.mehta@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary Objective- to investigate any improvement in disability associated with chronic migraine disorder in the two treatment arms ( GON block versus placebo procedure.) Secondary Objective- a. To assess change in participant headache frequency& severity, b. To assess the change in participant anxiety and depression levels, c. To assess the safety and tolerability in the two treatment arms (GON block versus placebo procedure) d. To assess the eligibility criteria recruitment and retention of participants in the two treatment arms. e. To assess the feasibility and acceptability of two treatment arms from the point of view of participants and their pain teams.
    Protection of trial subjects
    This study intends to provide more detailed information on the effectiveness, safety and tolerability of GON block with local anaesthetic and steroid in patents 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 entail an injection of 2ml of 2% lidocaine (a local anaesthetic) and 80mg 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
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jul 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment date: 12/Jul/2018, Patients aged over the age of 18 who are able to provide written consent. Ability to read and write English. Diagnosis of chronic migraine with or without acute relief medication overuse as confirmed by diary documentation.

    Pre-assignment
    Screening details
    		 A total 210 patients attended the neurology clinic at site where their suitability for the receive either the GON block (active group) or the placebo injection( control group) using sequentially numbered, opaque, sealed envelopes containing a previously- generated allocation sequence. Only the patients will be blinded to it.

    Period 1
    Period 1 title
    Intervention 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Active treatment (GON Block)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Depo-Medrone 40mg/mL and Lidocaine Hydrochloride 2% 5mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 ml mixture consisting 2 ml of 2% lidocaine and 80ml methylprednisolone

    Arm title
    		 Arm B
    Arm description
    		 Placebo procedure
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium Chloride 0.9% w/v 10mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravascular use
    Dosage and administration details
    Sodium Chloride 0.9% w/v 10mL

    Number of subjects in period 1
    		Arm A Arm B
    Started
    4
    4
    Completed
    2
    1
    Not completed
    2
    3
         Consent withdrawn by subject
    -
    2
         unblinded
    -
    1
         Lost to follow-up
    2
    -
    Period 2
    Period 2 title
    Intervention 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Placebo procedure
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium Chloride 0.9% w/v 10mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravascular use
    Dosage and administration details
    Sodium Chloride 0.9% w/v 10mL

    Arm title
    		 Arm B
    Arm description
    		 Active treatment (GON Block)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Depo-Medrone 40mg/mL and Lidocaine Hydrochloride 2% 5mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 ml mixture consisting 2 ml of 2% lidocaine and 80ml methylprednisolone

    Number of subjects in period 2
    		Arm A Arm B
    Started
    1
    2
    Completed
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention 1
    Reporting group description
    		 -

    Reporting group values
    		 Intervention 1 Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
    Subject analysis sets

    Subject analysis set title
    McNemar test
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    McNemar test will be used to assess the treatment differences in categorical variables and paired t test will be employed to evaluate the difference in secondary endpoints between GON and placebo as appropriate. For comparison of non-parametric variables between the GON and placebo, Wilcoxon sign ranked test will be used. Generalized linear mixed model which allow assessment of period and carryover effects from one treatment phase to another will also be applied to evaluate treatment differences in repeated measurements of primary and secondary endpoints. A p value less than 0.05 will be considered statistically significant. All data will be analysed on the intention-to-treat basis and missing values are replaced by the last observed value of that variable.

    Subject analysis sets values
    		 McNemar test
    Number of subjects
    1
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    1
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    1

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Active treatment (GON Block)

    Reporting group title
    Arm B
    Reporting group description
    		 Placebo procedure
    Reporting group title
    Arm A
    Reporting group description
    		 Placebo procedure

    Reporting group title
    Arm B
    Reporting group description
    		 Active treatment (GON Block)

    Subject analysis set title
    McNemar test
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    McNemar test will be used to assess the treatment differences in categorical variables and paired t test will be employed to evaluate the difference in secondary endpoints between GON and placebo as appropriate. For comparison of non-parametric variables between the GON and placebo, Wilcoxon sign ranked test will be used. Generalized linear mixed model which allow assessment of period and carryover effects from one treatment phase to another will also be applied to evaluate treatment differences in repeated measurements of primary and secondary endpoints. A p value less than 0.05 will be considered statistically significant. All data will be analysed on the intention-to-treat basis and missing values are replaced by the last observed value of that variable.

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    Primary Objective: Improvement in disability associated with chronic migraine disorder. Primary End Point: - change in Headache Impact Test (HIT-6) score - change in Migraine specific Questionnaire Score (MSQ) - change in the 12-item Short-Form Health Survey (SF-12) Questionnaire
    End point type
    Primary
    End point timeframe
    Maximum 24 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: We were unable to reach our object of recruiting 30 randomise patients to the study. Instead, we were only able to recruit 8 patients and had only 3 patients who completed the study. Due to the small number of patients recruited in this feasibility study, there will be no analysis.
    End point values
    		 Arm A Arm B Arm A Arm B McNemar test
    Number of subjects analysed
    4
    4
    1
    2
    8
    Units: score
        number (not applicable)
    2
    1
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Secondary Endpoints

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    End point title
    		 Secondary Endpoints
    End point description
    Secondary Objectives: - change in Headache frequency& Severity - change in anxiety and depression levels - safety and tolerability - eligibility criteria, recruitment and retention levels - feasibility and acceptability of the two treatment arms Secondary Endpoints: - Frequency and severity as scored in the HIT-6 questionnaire - Change in Hospital Anxiety and Depression Depression Scores (HADS) - Adverse events - Feedback from clinicians involved in recruitment - Number of participants that complete the study - Questionnaire upon completion of study asking participant if they found the treatment acceptable - Feedback from clinicians regarding overall feasibility and acceptability of two treatment arms
    End point type
    Secondary
    End point timeframe
    Maximum 24 weeks
    End point values
    		 Arm A Arm B Arm A Arm B
    Number of subjects analysed
    4
    4
    1
    2
    Units: score
        number (not applicable)
    2
    1
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Report Adverse Events (AEs) include events starting on or visit 1 until visit 5.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Intervention 2
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.13%
    Non-serious adverse events
    		 Intervention 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Infections and infestations
    Headache
    Additional description: Patient-reported increased left-sided heading and swelling following an intervention. The patient went to A&E for advice where was admitted for further test. The patient was discharged. Symptoms resolved after a week.
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2017
    The changes made in the protocol are mainly to indicate that the MHRA approved labels will no longer be used and that the IMPs involved in the study will be obtained from hospital stock.
    28 Jun 2017
    Study extension to 31 July 2018
    03 Apr 2018
    Clarification of recruitment sites in the protocol. Added Barts Health NHS Trust as a site.
    01 Jun 2018
    Study Extension to Dec 2019

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The GON block injections may have a therapeutic effect in controlling migraines. Due to small numbers in study and failure to achieve our expected recruitment target, it is difficult to conclude the hypothesis. Therefore, the study terminated early.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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