Phase 2
Completed N=15
Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population
Migraine Disorders · Headache, Migraine · Pediatrics
Source: ClinicalTrials.gov NCT03055767 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Frequency of Migraines — 28; 20; 28 days — p=0.038
Summary
The purpose of the research is to examine the outcomes of pediatric patients receiving Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric patients, specifically in the treatment of migraines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Migraines |
28; 20; 28 | 0.038 sig |
| PRIMARY Intensity of Migraines |
8; 5; 7 | 0.047 sig |
| PRIMARY Migraine Duration, in Hours |
24; 10; 24 | 0.148 |
| PRIMARY Pediatric Migraine Disability Score (PedMIDAS) |
4; 3; 4 | 0.047 sig |
| SECONDARY Functionality Improvement |
1; 0 | 0.002 sig |
| SECONDARY Difficulty Sleeping |
12; 5; 11 | 0.82 |
| SECONDARY Hospital Admissions |
8; 0; 2 | 0.006 sig |
| SECONDARY Emergency Department (ED) Visits |
8; 2; 3 | 0.039 sig |
| SECONDARY Home School |
2; 2; 2 | 0.016 sig |
| SECONDARY School Plan Enrollment |
11; 10; 10 | 0.18 |
| SECONDARY Duration of Benefit |
4; 0 | <0.001 sig |
| SECONDARY Concomitant Headache Medications |
3; 1; 2 | 0.64 |
Eligibility Criteria
Inclusion Criteria
- Children aged 8 - 17 years of age with a history of migraine meeting the criteria established in ICHD-II (2004), Section 1. Patients will provide at least 28-day baseline data in the form in the daily diary and must have at least 15 days of reported headache during this period, with at least 4 distinct episodes lasting at least 4 hours each.
Exclusion Criteria
- Previous use of botulinum toxin of any serotype for any reason
- Pregnancy.
- 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 of screening visit
Data sourced from ClinicalTrials.gov (NCT03055767). 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.