A Phase 4 interventional study of Onabotulinum toxin A in Migraine Disorders, sponsored by Corfu Headache Clinic. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-30.
Sponsored by Corfu Headache Clinic · Phase 4, Interventional, and Prevention
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Corfu Headache Clinic is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Cranial Subcutaneous Injections
Also known as: Botox
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)
Time frame: 3 years
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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