Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population
Condition: Migraine Disorders; Headache, Migraine; Pediatrics
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): OnabotulinumtoxinA; Placebo (Saline)
Intervention type(s): Drug; Other
Intervention description(s): The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.; The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment