NCT Number: NCT03055767
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.
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Notify Me8 year–17 year
All sexes
Interventional
Phase 2
Gottschalk Medical Plaza, Irvine, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Botox
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.
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
The frequency of migraines in days.
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Median intensity of migraines based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain.
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Duration of migraines in hours.
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Pediatric Migraine Disability Score consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.
The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4).
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Improvement of functionality as determined by their Pediatric Migraine Disability Score (PedMIDAS). The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.
The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4).
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Subject reported having difficulty sleeping
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Admission to hospital
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Subject visited an Emergency Department
Time frame: Baseline (4 weeks) and 12 weeks post, respective intervention
Subject is home schooled full-time.
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Subject is enrolled in a school plan such as IEP, 504 plan, or similar modified school schedule.
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
The duration of benefit in weeks
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Number of concomitant headache medications taken
Time frame: 24-48 weeks post-baseline period
The frequency of migraines during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.
Time frame: 24-48 weeks post-baseline period
Intensity of migraines during the the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.
Intensity based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain.
Time frame: 24-48 weeks post-baseline period
The PedMIDAS the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.
The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months.
The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4).
Time frame: 24-48 weeks post-baseline period
Duration of migraine in hours during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period.
University of California, Irvine
Other
Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Randomized Double Blinded Placebo Cross-over Study in the Pediatric Pain Population
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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