Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine

Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine Over 3 Years of Treatment. A

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Onabotulinum toxin A

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 years

Collaborators and Investigators

• Sponsor: Corfu Headache Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (ACTUAL): July 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: CorfuHC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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