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Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606356
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
KONSTANTINOS SPINGOS, Corfu Headache Clinic

Study Description
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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.


Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Onabotulinum toxin A Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single-arm, prospective multicentre, clinical study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine Over 3 Years of Treatment. A
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
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Intervention Details:
  • Drug: Onabotulinum toxin A
    Cranial Subcutaneous Injections
    Other Name: Botox

Outcome Measures
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Primary Outcome Measures :
  1. Change in the mean number of monthly headaches [ Time Frame: 3 years ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications:

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Responsible Party: KONSTANTINOS SPINGOS, Konstantinos Spingos MD, Neurologist, Corfu Headache Clinic
ClinicalTrials.gov Identifier: NCT03606356    
Other Study ID Numbers: CorfuHC2
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases