NCT00862095

Medical Therapies for Chronic Post-Traumatic Headaches

A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Madigan Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.

Detailed description

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.

Conditions

• Headache

Interventions

Type	Name	Description
DRUG	Placebo	Every month for 3 months
DRUG	Propranolol	target does 80 mg per day for 3 months
DRUG	Amitriptyline	Target does of 50 mg per day for 3 months
DRUG	Topiramate	Target dose 100 mg a day for 3 months

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2009-03-16
• Last updated: 2013-04-23

Locations

1 site across 1 country: United States