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

Allergan125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

125

Conditions

Migraine Disorders

Interventions

Botulinum toxin type A Dose 1BIOLOGICAL

Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.

Botulinum toxin type A Dose 2BIOLOGICAL

Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.

Placebo (Normal Saline)DRUG

Placebo (Normal Saline) intramuscular injections into specified muscles.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (22)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 12 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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