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    Clinical Trial Results:
    Definition of neuroimaging and laboratory biomarkers as possible predictors for treatment response to Galcanezumab in high-frequency episodic migraine (PREDICT)

    Summary
    EudraCT number
    		 2021-006176-16
    Trial protocol
    		 DE  
    Global end of trial date
    05 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2025
    First version publication date
    29 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I5Q-NS-O001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité- Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Kopfschmerzzentrum-Klinik für Neurologie, Charité - Universitätsmedizin Berlin , predict@charite.de
    Scientific contact
    Kopfschmerzzentrum-Klinik für Neurologie, Charité - Universitätsmedizin Berlin , predict@charite.de
    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
    14 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To test the hypothesis that a 3 months treatment with Galcanezumab results in structural and functional brain alterations and changes of CGRP blood levels in patients with high-frequency episodic migraine. The purpose of this study is to identify structural and functional neuroimaging and laboratory biomarkers (CGRP / PACAP, immune cell populations) that are altered in association with treatment with Galcanezumab in patients with high frequency episodic migraine. Data from this study will provide information on neuroimaging and blood markers that may help to identify patients who benefit from a prophylactic treatment with Galcanezumab.
    Protection of trial subjects
    The conduct of this study met all legal and regulatory requirements and in accordance with ethical principles of the Declaration of Helsinki. To ensure the safety of all participants, we scheduled follow-up appointments in our outpatient clinic within 8 weeks after the study's discontinuation
    Background therapy
    		 The exact mechanisms behind migraine initiation are not fully understood, although various molecular and cellular pathways have been identified.Recent findings in migraine MRI research suggest a pathoanatomic correlate of migraine burden in VBM, DTI and rs-fMRI with functional and structural changes in patients with EM or CM. Structural changes have been reported in response to conventional preventive treatment of chronic migraineurs in regions of the pain-processing network. CGRP, a key peptide in migraine pathophysiology, stimulates the release of pro-inflammatory cytokines such as Interleukin (IL)-1ß, IL-6, and Tumor Necrosis Factor Alpha, thereby causing and amplifying inflammation. Galcanezumab, a subcutaneous monoclonal CGRP antibody, is used to treat episodic and chronic migraine. In the present study, we aimed to deepen insights into multimodal pathophysiological changes by a CGRP treatment and evaluate potential predictors of response for a sufficient treatment.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Apr 2022
    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
    Germany: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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
    		 The study was conducted at one study center in Germany between 04/05/2023 and 05/06/2024.

    Pre-assignment
    Screening details
    		 ......were screened according the inclusion and exclusion criteria

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a single-arm study. Healthy controls without treatment served as the control group. The same inclusion criteria apply for healthy controls except for a history of migraine.

    Arms
    Arm title
    		 Treatment group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab
    Investigational medicinal product code
    Other name
    Emagility
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    The investigational product dose was 240 mg/1 ml as a loading dose was administered at baseline. The second administration date was scheduled in 30-day increments (+/– 2 days) from the first dose. At one and two months later patients received 120 mg/ 1ml subcutaneous injection with an autoinjector.

    Number of subjects in period 1
    		Treatment group
    Started
    8
    Completed
    7
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 -

    Primary: changes of CGRP blood levels

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    End point title
    		 changes of CGRP blood levels [1]
    End point description
    An analysis of the primary endpoint on MRI data and changes CGRP blood levels was impossible due to missing data after an early discontinuation of the study.
    End point type
    Primary
    End point timeframe
    after 3 months
    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: An analysis of the primary endpoint on MRI data was impossible due to missing data after an early discontinuation of the study
    End point values
    		 Treatment group
    Number of subjects analysed
    8
    Units: pg/mL
    arithmetic mean (standard error)
        missing data
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Reduction in monthly migraine days

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    End point title
    		 Reduction in monthly migraine days
    End point description
    End point type
    Secondary
    End point timeframe
    after 3 months
    End point values
    		 Treatment group
    Number of subjects analysed
    8
    Units: days
    number (not applicable)
        at baseline
    11.6
        after 3 months
    5.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    General disorders and administration site conditions
    allergic skin reaction
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2023
    -change head of clinical trial

    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.
    Due to recruitment challenges and the unexpected change of the principal investigator, the study was unable to meet its enrollment target of at least 64 participants with migraine and 25 healthy controls.
    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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