Recruitment

Recruitment Status
Completed
Estimated Enrollment
400

Inclusion Criteria

More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
History of chronic migraine
More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
History of chronic migraine

Exclusion Criteria

Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Previous treatment with botulinum toxin of any serotype for any reason
...
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Previous treatment with botulinum toxin of any serotype for any reason
On a ketogenic diet (high in fat, low in carbohydrates)
Previous treatment with topiramate
History of acute myopia or increased intraocular pressure
Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period

Summary

Conditions
Migraine Disorders
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criteria

More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
History of chronic migraine
More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
History of chronic migraine

Exclusion Criteria

Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Previous treatment with botulinum toxin of any serotype for any reason
...
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Previous treatment with botulinum toxin of any serotype for any reason
On a ketogenic diet (high in fat, low in carbohydrates)
Previous treatment with topiramate
History of acute myopia or increased intraocular pressure
Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period

Locations

Saint Louis, Missouri, 63141
Amherst, New York, 14226
Encinitas, California, 92024
Riverwoods, Illinois, 60015
Newport Beach, California, 92663
...
Saint Louis, Missouri, 63141
Amherst, New York, 14226
Encinitas, California, 92024
Riverwoods, Illinois, 60015
Newport Beach, California, 92663
Greensboro, North Carolina, 27405
Overland Park, Kansas, 66211
Denver, Colorado, 80210
Sarasota, Florida, 34239
Plainview, New York, 11803
Gulf Breeze, Florida, 32561
Reno, Nevada, 89502
Bronx, New York, 10461
Stamford, Connecticut, 06905
Wynnewood, Pennsylvania, 19096
Jackson, Michigan, 49201
Tacoma, Washington, 98409
Asheville, North Carolina, 28806
Boca Raton, Florida, 33486
Phoenix, Arizona, 85013
Philadelphia, Pennsylvania, 19107
Raleigh, North Carolina, 27607
Overland Park, Kansas, 66210
Dallas, Texas, 75214
Pittsburgh, Pennsylvania, 15236
Doral, Florida, 33172
Fresno, California, 93723
Springfield, Missouri, 65807
West Palm Beach, Florida, 33407
Baton Rouge, Louisiana, 70810
Watertown, Massachusetts, 02472
Worcester, Massachusetts, 01605

Tracking Information

NCT #
NCT02191579
Collaborators
Not Provided
Investigators
Study Director: Esther Jo Allergan