A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

Study Overview
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Brief Summary
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This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.

Conditions
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Migraine Disorders

Intervention / Treatment
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* Biological: onabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) Exclusion Criteria: Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis Headache attributed to another disorder Infection or skin disorder at injection sites Previous treatment with botulinum toxin of any serotype for any reason Anticipated need for botulinum toxin of any type for any reason during the course of the study Previous participation in any botulinum toxin clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX®<br>Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas. | Biological: onabotulinumtoxinA<br>* Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.<br>* Other names: botulinum toxin Type A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Frequency of Headache Days | Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement. | Baseline, Week 108 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Frequency of Headache Days | Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement. | Baseline, Week 60 | 
| Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score | The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening. | Baseline, Week 60, Week 108 |