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
Overview
- Phase
- Phase 3
- Intervention
- Botulinum toxin type A Dose 1
- Conditions
- Migraine Disorders
- Sponsor
- Allergan
- Enrollment
- 125
- Locations
- 22
- Primary Endpoint
- Change From Baseline in the Frequency of Headache Days
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Intervention: Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Intervention: Botulinum toxin type A Dose 2
Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
Intervention: Placebo (Normal Saline)
Outcomes
Primary Outcomes
Change From Baseline in the Frequency of Headache Days
Time Frame: Baseline, 12 Weeks
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.
Secondary Outcomes
- Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days(Baseline, 12 Weeks)
- Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment(12 Weeks)
- Change From Baseline in the Frequency of Severe Headache Days(Baseline, 12 Weeks)
- Change From Baseline in the Total Cumulative Hours of Headache on Headache Days(Baseline, 12 Weeks)