Recruitment

Recruitment Status
Completed
Estimated Enrollment
400

Inclusion Criteria

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

Exclusion Criteria

Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
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.
Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
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
Previous treatment with botulinum toxin of any serotype for any reason
History of acute myopia or increased intraocular pressure
On a ketogenic diet (high in fat, low in carbohydrates)

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

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

Exclusion Criteria

Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
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.
Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
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
Previous treatment with botulinum toxin of any serotype for any reason
History of acute myopia or increased intraocular pressure
On a ketogenic diet (high in fat, low in carbohydrates)

Tracking Information

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