Migraine Disorders Clinical Trial
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
Verified date | October 2016 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan |
United States | Associated Neurologists of Southern CT, P.C. | Fairfield | Connecticut |
United States | Fullerton Neurology and Headache Center | Fullerton | California |
United States | NW FL Clinical Research Group, LLC | Gulf Breeze | Florida |
United States | Josephson Wallack Munshower Neurology, P.C. | Indianapolis | Indiana |
United States | Advanced Clinical Research | Meridian | Idaho |
United States | Nashville Neuroscience Group | Nashville | Tennessee |
United States | The Research Center of Southern California | Oceanside | California |
United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
United States | Pediatric Neurology, PA | Orlando | Florida |
United States | CPFCC Neurology Research Department | Overland Park | Kansas |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Jill Waldo, CCRC | Pittsburgh | Pennsylvania |
United States | Renown Institution for Neurosciences | Reno | Nevada |
United States | Rochester Clinical Research, Inc | Rochester | New York |
United States | Wasatch Clinical Research | Salt Lake City | Utah |
United States | Texas Association of Pediatric Neurology/Road Runner Research | San Antonio | Texas |
United States | San Francisco Clinical Research Center | San Francisco | California |
United States | CORE (Center for Outpatient Research) | Springfield | Missouri |
United States | New England Institute for Clinical Research | Stamford | Connecticut |
United States | Stanford Hospital and Clinics | Stanford | California |
United States | The Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the frequency of headache days | Baseline, 12 Weeks | No | |
Secondary | Change from baseline in the frequency of severe headache days | Baseline, 12 Weeks | No | |
Secondary | Change from baseline in the total cumulative hours of headache on headache days | Baseline, 12 Weeks | No | |
Secondary | Percentage of patients with = 50% decrease from baseline in the frequency of headache days | Baseline, 12 Weeks | No | |
Secondary | Percentage of patients who are prescribed oral rescue migraine prophylactic treatment | 12 Weeks | No |
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