Recruitment

Recruitment Status
Completed
Estimated Enrollment
400

Inclusion Criterias

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 Criterias

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

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 Criterias

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 Criterias

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

Locations

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

Tracking Information

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