Phase 3 N=125 Randomized Triple-blind Treatment

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

Migraine Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01662492 ↗

Enrolled (actual)

125

Serious AEs

2.4%

Results posted

Sep 2017

Primary outcome: Primary: Change From Baseline in the Frequency of Headache Days — 23.2; 23.4; 25.3; -6.3 Headache days

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Botulinum toxin type A Dose 1 (Biological); Botulinum toxin type A Dose 2 (Biological); Placebo (Normal Saline) (Drug)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Frequency of Headache Days	23.2; 23.4; 25.3; -6.3; -6.4; -6.8	—
SECONDARY Change From Baseline in the Frequency of Severe Headache Days	7.0; 7.8; 9.1; -1.3; -2.3; -0.9	—
SECONDARY Change From Baseline in the Total Cumulative Hours of Headache on Headache Days	170.69; 175.98; 212.68; -36.52; -19.03; -50.04	—
SECONDARY Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days	28.9; 32.6; 29.7	—
SECONDARY Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment	0; 0; 0; 4.4; 9.3; 2.7	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT01662492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.