Overview

This trial is active, not recruiting.

Condition migraine disorders
Treatment onabotulinumtoxin a
Phase phase 4
Sponsor Allergan
Start date July 2015
End date September 2016
Trial size 644 participants
Trial identifier NCT01686581, MAF/AGN/NS/CM/002

Summary

This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Onabotulinumtoxin A (BOTOX®) administered according to physician prescription; all treatment decisions lie with the physician.
onabotulinumtoxin a BOTOX®
Onabotulinumtoxin A (BOTOX®) administered according to physician prescription; all treatment decisions lie with the physician.

Primary Outcomes

Measure
Healthcare Resource Utilization Using a Patient Questionnaire
time frame: 24 Months

Secondary Outcomes

Measure
EuroQol Group EQ-5D Questionnaire Score
time frame: 24 Months
Headache Frequency
time frame: 24 Months
Patient Treatment Satisfaction Using a 4-Point Scale
time frame: 24 Months
Migraine Specific Quality of Life Questionnaire (MSQ) Score
time frame: 24 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Prescribed BOTOX® for the prophylaxis of headaches Exclusion Criteria: - Received treatment with any botulinum toxin Type A serotype in the last 26 weeks - Current participation in Allergan's Botox Chronic Migraine Post-Authorisation Safety Study (protocol 191622-110)

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Allergan.