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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055767
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
American Society of Regional Anesthesia
Information provided by (Responsible Party):
Shalini Suresh Shah, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE February 8, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • Pain scores (Intensity) [ Time Frame: 12 months ]
    (standardized numerical rating scale);
  • Change in duration of migraine episode [ Time Frame: 12 months ]
    (chart history)
  • Frequency of Migraine [ Time Frame: 12 months ]
    (chart history);
  • Disability and Functionality [ Time Frame: 12 months ]
    (chart history); PediMIDAS scoring
  • Opioid Consumption [ Time Frame: 12 months ]
    Amount of opioid medication consumed (chart history)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Duration of benefit of onabotulinumtoxinA therapy [ Time Frame: 12 months ]
    chart history
  • Associated side effects [ Time Frame: 12 months ]
    incidence of nausea, vomiting, food intake, diarrhea, constipation, anxiety, depression
  • Adverse Event (AE) related to onabotulinumtoxin A [ Time Frame: 12 months ]
    (chart history)
  • Rescue medication use/change [ Time Frame: 12 months ]
    chart review
  • Hospital and Emergency Department (ED) utilization [ Time Frame: 12 months ]
    chart review
  • Current medication use [ Time Frame: 12 months ]
    Increase, Decrease or no change in concomitant headache medication
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • Duration of benefit of onabotulinumtoxinA therapy [ Time Frame: 12 months ]
    chart history
  • Associated side effects [ Time Frame: 12 months ]
    incidence of nausea, vomiting, food intake, diarrhea, constipation, anxiety, depression
  • AE related to onabotulinumtoxin A [ Time Frame: 12 months ]
    (chart history)
  • Rescue medication use/change [ Time Frame: 12 months ]
    chart review
  • Hospital and ED utilization [ Time Frame: 12 months ]
  • Current medication use [ Time Frame: 12 months ]
    Increase, Decrease or no change in concomitant headache medication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population
Official Title  ICMJE Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Randomized Double Blinded Placebo Cross-over Study in the Pediatric Pain Population
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine Disorders
  • Headache, Migraine
  • Pediatrics
Intervention  ICMJE
  • Drug: OnabotulinumtoxinA
    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 Name: Botox
  • Other: Placebo (Saline)
    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.
Study Arms  ICMJE
  • OnabotulinumtoxinA/Saline Placebo
    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.
    Interventions:
    • Drug: OnabotulinumtoxinA
    • Other: Placebo (Saline)
  • Saline Placebo/OnabotulinumtoxinA
    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.
    Interventions:
    • Drug: OnabotulinumtoxinA
    • Other: Placebo (Saline)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 17, 2020)
17
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
26
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055767
Other Study ID Numbers  ICMJE UCIANES09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shalini Suresh Shah, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE American Society of Regional Anesthesia
Investigators  ICMJE
Principal Investigator: Shalini S Shah, MD Assistant Clinical Professor
PRS Account University of California, Irvine
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP