Clinical trial NCT01662492: A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 125
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Medical history of chronic migraine for at least 6 months
* 15 or more headache days during a 4 week period

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in the Frequency of Headache Days
timeFrame: Baseline, 12 Weeks
Secondary outcomes:
measure: Change From Baseline in the Frequency of Severe Headache Days
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
timeFrame: Baseline, 12 Weeks
measure: Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
timeFrame: Baseline, 12 Weeks
measure: Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: Oceanside
country: United States
facility: The Research Center of Southern California
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT, P.C.
state: Connecticut
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group, LLC
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurology, PA
state: Florida
city: West Palm Beach
country: United States
facility: The Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, P.C.
state: Indiana
city: Overland Park
country: United States
facility: CPFCC Neurology Research Department
state: Kansas
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Springfield
country: United States
facility: CORE (Center for Outpatient Research)
state: Missouri
city: Reno
country: United States
facility: Renown Institution for Neurosciences
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Pittsburgh
country: United States
facility: Jill Waldo, CCRC
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: San Antonio
country: United States
facility: Texas Association of Pediatric Neurology/Road Runner Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.