Migraine Disorders Clinical Trial
Official title:
Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine Over 3 Years of Treatment. A
Verified date | July 2018 |
Source | Corfu Headache Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | April 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Corfu Headache Clinic |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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