Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

Study Overview
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Brief Summary
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This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.

Official Title
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A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

Conditions
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Migraine Disorders

Intervention / Treatment
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* Biological: botulinum toxin Type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Has successfully completed the double-blind study (1313-301-008). Exclusion Criteria: Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma) Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX®<br>BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections to head/neck areas at Day 0 and Week 12. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.<br>* Other names: onabotulinumtoxinA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. | 24 Weeks | 
| Percentage of Participants with AEs Leading to Discontinuation |  | 24 Weeks | 
| Change from Baseline in Vital Signs | Vital signs include blood pressure and pulse. | Baseline, Week 24 | 
| Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters | A standard 12-lead ECG will be performed at Baseline and Week 24. | Baseline, Week 24 | 
| Change from Baseline in Clinical Laboratory Parameters | Blood samples will be collected at Baseline and Week 24 for standard clinical laboratory testing including hematology, chemistry, urinalysis an immunogenicity parameters. | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24 | Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 12 and 24. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary. | Baseline, Weeks 12 and 24 | 
| Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period | Mean change from Baseline (28-days prior to first treatment) in the total cumulative hours of headache days during the 28-day period ending with Weeks 12 and 24. A headache day is defined as a day (00:00 to 23:59) with 4 or more continuous hours of headache per patient diary. | Baseline, Weeks 12 and 24 |