Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606356
• Other study ID #: CorfuHC2
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2015
• Est. completion date: April 1, 2018

Study information

• Verified date: July 2018
• Source: Corfu Headache Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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:

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Onabotulinum toxin A
Cranial Subcutaneous Injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corfu Headache Clinic

References & Publications (1)

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

Outcome

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