Phase 3
Completed N=125
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
Migraine Disorders
Source: ClinicalTrials.gov NCT01662492 ↗
Enrolled (actual)
125
Serious AEs
2.4%
Results posted
Sep 2017
Primary outcomePrimary: Change From Baseline in the Frequency of Headache Days — 23.2; 23.4; 25.3; -6.3 Headache days
◆ Published Evidence
Established
31citations · ~4 / year
Onabotulinumtoxin A (BOTOX®) for ProphylaCTIC Treatment of Pediatric Migraine: A Retrospective Longitudinal Analysis.
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.
Linked Publications
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Onabotulinumtoxin A (BOTOX®) for ProphylaCTIC Treatment of Pediatric Migraine: A Retrospective Longitudinal Analysis.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01662492) and the linked publication. 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. Informational only — not medical advice.