A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

Phase 3

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Placebo (Normal Saline); Biological: Botulinum toxin type A Dose 1; Biological: Botulinum toxin type A Dose 2

• Registration Number: NCT01662492
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-10
• Study Start: 2012-10
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-07
• Results First Submitted: 2017-08-03
• Results First Submitted QC: 2017-08-03
• Last Update Submitted: 2017-08-03
• Results First Posted: 2017-09-05
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Normal Saline)	Placebo (Normal Saline)	Placebo (Normal Saline) intramuscular injections into specified muscles.
Botulinum toxin type A Dose 1	Botulinum toxin type A Dose 1	Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2	Botulinum toxin type A Dose 2	Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Frequency of Headache Days	Baseline, 12 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days	Baseline, 12 Weeks	Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment	12 Weeks	Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.
Change From Baseline in the Frequency of Severe Headache Days	Baseline, 12 Weeks	Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days	Baseline, 12 Weeks	Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.

Trial Locations

Locations (22)

New England Institute for Clinical Research; 🇺🇸 Stamford, Connecticut, United States

Fullerton Neurology and Headache Center; 🇺🇸 Fullerton, California, 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

Associated Neurologists of Southern CT, P.C.; 🇺🇸 Fairfield, Connecticut, United States

NW FL Clinical Research Group, LLC; 🇺🇸 Gulf Breeze, Florida, United States

The Premiere Research Institute at Palm Beach Neurology; 🇺🇸 West Palm Beach, Florida, United States

Advanced Clinical Research; 🇺🇸 Meridian, Idaho, United States

CPFCC Neurology Research Department; 🇺🇸 Overland Park, Kansas, United States

Josephson Wallack Munshower Neurology, P.C.; 🇺🇸 Indianapolis, Indiana, United States

CORE (Center for Outpatient Research); 🇺🇸 Springfield, Missouri, United States

Rochester Clinical Research, Inc; 🇺🇸 Rochester, New York, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Jill Waldo, CCRC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Wasatch Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Pediatric Neurology, PA; 🇺🇸 Orlando, Florida, United States

Michigan Head Pain & Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

Renown Institution for Neurosciences; 🇺🇸 Reno, Nevada, United States

Nashville Neuroscience Group; 🇺🇸 Nashville, Tennessee, United States

The Research Center of Southern California; 🇺🇸 Oceanside, California, United States

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States