An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine

Study Overview
=================
Brief 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.

Official Title
-----------------
A 24-month, Prospective, Non-interventional Study to Describe the Long Term, Real-Life Use of BOTOX® for the Symptomatic Treatment of Adults With Chronic Migraine, Measuring Healthcare Resource Utilization, and Patient Reported Outcomes Observed in Practice

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BOTOX®<br>BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician. | Drug: botulinum toxin Type A<br>* Botulinum toxin Type A (BOTOX®) administered according to physician prescription.<br>* Other names: onabotulinumtoxin A;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Admitted to the Hospital for Headache | The Baseline value included participants who had been admitted to the hospital for headache in the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included participants who been admitted to the hospital for headache since the previous visit. | Baseline (previous 3 months prior to first dose of BOTOX®) and Last Follow-up Visit (FU last) [median 21.20 months] | 
| Mean Number of Days of Headache-related Hospital Admissions | The number of admission days is presented as the mean, normalized to a period of 90 days. The Baseline value included admissions during the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included admissions since the second-to-last visit. | Baseline (previous 3 months prior to first dose of BOTOX@) to FU last [median 21.20 months] | 
| Percentage of Participants Who Visited Any Healthcare Professional (HCP) | The Baseline value included participants who had visited an HCP in the last 3 months prior to the baseline visit (first administration of Botox); the value for FU last included participants who visited an HCP since the second-to-last visit. | Baseline (previous 3 months prior to first dose of BOTOX®) to FU last [median 21.20 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score | The MSQ is a 14-item questionnaire to measure health-related quality-of-life attributed to migraine in the past 4 weeks. Each item is scored on a 6-point scale where: 1=none of the time to 6=all of the time. There are 3 dimensions: Role-function Restrictive (questions 1 to 7; score range 7 to 42), Role-function Preventive (questions 8 to 11; score range 4 to 24) and Emotional-function (questions 12 to 14; score range 3 to 18). The individual dimension scores were converted to a score of 0 to 100; the total score ranged from 0 to 300 with higher numbers representing a better quality of life. A positive change from baseline in the dimension scores and the total score indicates that quality of life has improved. | Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months] | 
| Change From Baseline in the EQ-5D Questionnaire Total Score | The EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) assessed by the participant using a 3-point scale: 1=no problems, 2=some problems and 3=extreme problems. The combination of levels from the 5 dimensions results in a health state code. The total score is calculated by converting the health state code into a score: start with score 1.000=[11111] (perfect health state), subtract 0.081 (constant) for any other state, subtract nothing for level 1 on any dimension, subtract appropriate level 2 or level 3 value for each dimension from a table of constants [Level 2: Mobility 0.069, Self-care 0.104, Usual activity 0.036, Pain/discomfort 0.123, Anxiety/depression 0.071] [Level 3: Mobility 0.314, Self-care 0.214, Usual activity 0.094, Pain/discomfort 0.386, Anxiety/depression 0.236], subtract 0.269 if any dimension has a level 3 problem. Higher numbers indicate better health. A positive change from Baseline indicates improvement. | Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months] | 
| Change From Baseline in the Health State Score of the EQ-5D Questionnaire | The EQ-5D health state scale is a visual analog scale that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better state of health. Participants were asked to rate their health state on a drawn line that started at 0 and ended at 100. A positive change from baseline in the health state score indicates that the participant's health state has improved. | Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months] | 
| Change From Baseline in the Number of Headache Days | At each visit, participants were asked to provide the number of headache days he/she experienced in the last month. A headache day was defined as 4 or more hours of continuous headache. A negative change from Baseline (less headache days) indicates improvement. | Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months] | 
| Percentage of Participants With Good or Very Good Responses on the 4-Point Treatment Satisfaction Scale | At each visit, participants and physicians were asked to indicate the level of satisfaction that he/she had with the treatment. Physicians indicated the level of satisfaction with the patient's treatment. The 4- point scale consisted of the following responses: insufficient, moderate, good and very good. The combined percentage of good and very good responses by participants and physicians are reported. | ADM last [median 20.30 months] |