Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population

Phase

Condition

Migraine (Adult)

Oral Facial Pain

Pain (Pediatric)

Treatment

OnabotulinumtoxinA

Placebo (Saline)

Clinical Study ID

NCT03055767

20163108

UCIANES09

Ages 8-17
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Children aged 8 - 17 years of age with a history of migraine meeting the criteriaestablished in ICHD-II (2004), Section 1. Patients will provide at least 28-daybaseline data in the form in the daily diary and must have at least 15 days ofreported headache during this period, with at least 4 distinct episodes lasting atleast 4 hours each.

Exclusion

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 weeksprior to the week of screening visit

Study Design

OnabotulinumtoxinA

March 01, 2017

April 20, 2020

Study Description

Medical Literature approximates one in three children will experience chronic headaches in their lifetime, which increases as children reach adolescence. Migraines make up nearly 60% of all visits to a pediatric headache specialist. Studies have demonstrated the negative impact of having childhood migraine on overall quality of life is similar to pediatric cancer, heart disease and rheumatic disease. As the frequency of migraine attacks increase, so does proportionally the child's disability in lost school time and family and social interactions, all of which may lead in turn to economic disability. Studies estimate the health care costs are 70% higher for a family with a migraine than a non-migraine affected family, and direct medical costs for children with migraine are reported to be similar to those for adults. A study published in JAMA 2003 found that health care costs, work-related disability for parents and lost educational opportunity for the child leads to an annual economic impact in the US of approximately $36 billion due to both direct medical costs and lost productivity into adulthood.

Onaboutlinum (BOTOX) is currently FDA approved as a very successful treatment to prevent migraines in adults, however not yet children. Current treatments for migraine in children appear to be insufficient. No trials currently exist in literature prospectively studying onabotulinumtoxinA for efficacy and/or safety for indication of pediatric migraine, although significant contributions have been made by retrospective case series over the last 10 years.

This research will be the first investigator-initiated study to study BOTOX (R) in children prospectively in a randomized controlled placebo, cross-over study. The overriding rationale is to demonstrate efficacy, tolerability and safety of onabotulinumtoxinA for pediatric migraine and thereby potentially hasten the lengthy process to evaluate BOTOX® for approval in the pediatric population.

Connect with a study center

Gottschalk Medical Plaza
Irvine, California 92697
United States
Site Not Available
UC Irvine Medical Center
Orange, California 92868
United States
Site Not Available

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