A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Official Title
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191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine

Conditions
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Migraine Disorders

Intervention / Treatment
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* Biological: Botulinum toxin type A Dose 1
* Biological: Botulinum toxin type A Dose 2
* Drug: Placebo (Normal Saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical history of chronic migraine for at least 6 months 15 or more headache days during a 4 week period Exclusion Criteria: Previous use of any botulinum toxin of any serotype for any reason Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A Dose 1<br>Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. | Biological: Botulinum toxin type A Dose 1<br>* Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.<br>* Other names: BOTOX®;|
| Experimental: Botulinum toxin type A Dose 2<br>Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. | Biological: Botulinum toxin type A Dose 2<br>* Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.<br>* Other names: BOTOX®;|
| Placebo Comparator: Placebo (Normal Saline)<br>Placebo (Normal Saline) intramuscular injections into specified muscles. | Drug: Placebo (Normal Saline)<br>* Placebo (Normal Saline) intramuscular injections into specified muscles.<br>|

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 | Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary. | Baseline, 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Frequency of Severe Headache Days | Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary. | Baseline, 12 Weeks | 
| Change From Baseline in the Total Cumulative Hours of Headache on Headache Days | Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days. | Baseline, 12 Weeks | 
| Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days | Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days. | Baseline, 12 Weeks | 
| Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment | Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population. | 12 Weeks |