Medical Therapies for Chronic Post-Traumatic Headaches

Phase 4

Terminated

• Conditions: Headache
• Interventions: Drug: Placebo; Drug: Propranolol; Drug: Topiramate; Drug: Amitriptyline

• Registration Number: NCT00862095
• Lead Sponsor: Madigan Army Medical Center

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo group
Propranolol	Propranolol	Propranolol (target dose 80 mg a day)
Topiramate	Topiramate	Topiramate (target dose 100 mg a day)
Amitriptyline	Amitriptyline	Amitriptyline (target dose 50 mg a day)

Primary Outcome Measures

Name	Time	Method
Headache days per month on the third month of treatment	Monthly for 4 weeks

Trial Locations

Locations (1)

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States