Headache Clinical Trial
Official title:
A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches
To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
A total of 240 patients meeting International Classification of Headache Disorders (ICHD)
diagnostic criteria for chronic post-traumatic headaches will be enrolled. Subjects will be
recruited from the Neurology Clinic at Madigan Army Medical Center. Study participants will
be U.S. Army soldiers who sustained a mild traumatic head injury while deployed to a combat
theater resulting in chronic post-traumatic headaches. Subjects will be randomized to
placebo, propranolol (target dose 80 mg a day), amitriptyline (target dose 50 mg a day), or
topiramate (target dose 100 mg a day) for 3 months.
The primary outcome measure will be the mean number of headache days per month on the third
month of treatment. Secondary outcome measures will include the proportion of subjects with
at least a 25% reduction in headache frequency, headache severity (0-10 scale), headache
duration (hours), headache-related disability (measured by the Headache Impact Test and
Migraine Disability Assessment Scale), PTSD symptom checklist score, and medication side
effects and tolerability.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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