We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03055767
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified March 2017 by Shalini Suresh Shah, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03055767
First Posted: February 16, 2017
Last Update Posted: March 3, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
American Society of Regional Anesthesia
Information provided by (Responsible Party):
Shalini Suresh Shah, University of California, Irvine
  Purpose
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.

Condition Intervention Phase
Migraine Disorders Headache, Migraine Pediatrics Drug: OnabotulinumtoxinA Other: Placebo (Saline) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Randomized Double Blinded Placebo Cross-over Study in the Pediatric Pain Population

Resource links provided by NLM:


Further study details as provided by Shalini Suresh Shah, University of California, Irvine:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 26
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055767


Contacts
Contact: Shalini S Shah, MD 714-456-5059 ssshah1@uci.edu
Contact: Joseph B Rinehart, MD 714-456-5059 jrinehar@uci.edu

Locations
United States, California
Gottschalk Medical Plaza Recruiting
Irvine, California, United States, 92697
Contact: Shalini S Shah, MD    714-456-5059    ssshah1@uci.edu   
Contact: Michael-David Calderon, BS    714-456-7800 ext 120-2464    mccalder@uci.edu   
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Michael-David Calderon, BS    714-456-7800 ext 2464    mccalder@uci.edu   
Principal Investigator: Shalini Shah, MD         
Sub-Investigator: Joseph Rinehart, MD         
Sponsors and Collaborators
University of California, Irvine
American Society of Regional Anesthesia
Investigators
Principal Investigator: Shalini S Shah, MD Assistant Clinical Professor
  More Information

Publications:

Responsible Party: Shalini Suresh Shah, Assistant Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03055767     History of Changes
Other Study ID Numbers: UCIANES09
First Submitted: February 8, 2017
First Posted: February 16, 2017
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents