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Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Onabotulinum toxin A
Sponsored by
Corfu Headache Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with chronic migraine according to IHC-III with or without medication overuse.
  • Responders defined as patients that after 3 sessions of treatment with onabutulinum toxin A, having experienced a ≥50% reduction in their average monthly migraine days

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in the mean number of monthly headaches
    Change in the mean number of monthly headache days, from the third administration (months 10 to 12; T1) to the period after three years of treatment (months 37-39; T3)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2018
    Last Updated
    July 27, 2018
    Sponsor
    Corfu Headache Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03606356
    Brief Title
    Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine
    Official Title
    Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine Over 3 Years of Treatment. A
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (Actual)
    Primary Completion Date
    April 1, 2018 (Actual)
    Study Completion Date
    April 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Corfu Headache Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To assess whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in chronic migraine over more than three years of treatment. We prospectively enrolled 65 chronic migraine patients, who were classified as responders after three sessions of onabotulinumtoxin A and were eligible to further continue treatment.
    Detailed Description
    Evidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. This study aims at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxin A sessions in CM over more than three years of treatment. This study prospectively enrolled 65 CM patients, who were classified as responders after three sessions of onabotulinumtoxinA and were eligible to further continue treatment. Data documenting longitudinal changes from the trimester after the third onabotulinumtoxinA administration (T1) to the trimester after completing two years of treatment (T2) and eventually to the trimester after completing three years of treatment (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of >4/10, and (iii) mean number of days with use of any acute headache medication, were prospectively collected from patients' headache diaries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine Disorders

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open-label, single-arm, prospective multicentre, clinical study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Onabotulinum toxin A
    Other Intervention Name(s)
    Botox
    Intervention Description
    Cranial Subcutaneous Injections
    Primary Outcome Measure Information:
    Title
    Change in the mean number of monthly headaches
    Description
    Change in the mean number of monthly headache days, from the third administration (months 10 to 12; T1) to the period after three years of treatment (months 37-39; T3)
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with chronic migraine according to IHC-III with or without medication overuse. Responders defined as patients that after 3 sessions of treatment with onabutulinum toxin A, having experienced a ≥50% reduction in their average monthly migraine days Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27640152
    Citation
    Vikelis M, Argyriou AA, Dermitzakis EV, Spingos KC, Mitsikostas DD. Onabotulinumtoxin-A treatment in Greek patients with chronic migraine. J Headache Pain. 2016 Dec;17(1):84. doi: 10.1186/s10194-016-0676-z. Epub 2016 Sep 17.
    Results Reference
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    Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine

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