A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine
1 other identifier
interventional
125
1 country
22
Brief Summary
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2012
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
September 5, 2017
CompletedSeptember 5, 2017
July 1, 2017
3.8 years
August 8, 2012
August 3, 2017
August 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Frequency of Headache Days
Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.
Baseline, 12 Weeks
Secondary Outcomes (4)
Change From Baseline in the Frequency of Severe Headache Days
Baseline, 12 Weeks
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
Baseline, 12 Weeks
Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Baseline, 12 Weeks
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
12 Weeks
Study Arms (3)
Botulinum toxin type A Dose 1
EXPERIMENTALBotulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2
EXPERIMENTALBotulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Placebo (Normal Saline)
PLACEBO COMPARATORPlacebo (Normal Saline) intramuscular injections into specified muscles.
Interventions
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Placebo (Normal Saline) intramuscular injections into specified muscles.
Eligibility Criteria
You may qualify if:
- Medical history of chronic migraine for at least 6 months
- or more headache days during a 4 week period
You may not qualify if:
- Previous use of any botulinum toxin of any serotype for any reason
- 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 -4 screening visit
- Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (22)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
The Research Center of Southern California
Oceanside, California, 92056, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, 06824, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561, United States
Pediatric Neurology, PA
Orlando, Florida, 32819, United States
The Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Josephson Wallack Munshower Neurology, P.C.
Indianapolis, Indiana, 46237, United States
CPFCC Neurology Research Department
Overland Park, Kansas, 66212, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
CORE (Center for Outpatient Research)
Springfield, Missouri, 65804, United States
Renown Institution for Neurosciences
Reno, Nevada, 89502, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Jill Waldo, CCRC
Pittsburgh, Pennsylvania, 15236, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
Texas Association of Pediatric Neurology/Road Runner Research
San Antonio, Texas, 78258, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Related Publications (1)
Shah S, Calderon MD, Wu W, Grant J, Rinehart J. Onabotulinumtoxin A (BOTOX(R)) for ProphylaCTIC Treatment of Pediatric Migraine: A Retrospective Longitudinal Analysis. J Child Neurol. 2018 Aug;33(9):580-586. doi: 10.1177/0883073818776142. Epub 2018 Jun 7.
PMID: 29877131DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2012
First Posted
August 10, 2012
Study Start
October 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 5, 2017
Results First Posted
September 5, 2017
Record last verified: 2017-07