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

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

Tracking Information

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