Medical Therapies for Chronic Post-Traumatic Headaches
Information source: Madigan Army Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Headache
Intervention: Placebo (Drug); Propranolol (Drug); Amitriptyline (Drug); Topiramate (Drug)
Phase: Phase 4
Sponsored by: Madigan Army Medical Center
Official(s) and/or principal investigator(s):
Jay Erickson, MD, Principal Investigator, Affiliation: Madigan Army Medical Center
To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in
patients with chronic post-traumatic headaches.
Official title: A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Headache days per month on the third month of treatment
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.
Minimum age: 18 Years.
Maximum age: 50 Years.
1. Patient meets ICHD criteria for chronic post-traumatic headaches (see below).
2. Patient is 18-50 years old.
3. Patient has experienced 6 or more days of headache per month for each of the last 2
4. Patient has full capacity to provide informed consent.
5. Patient will be available for all study-related visits over the next 4 months.
6. Patient must be eligible to receive care at Madigan Army Medical Center
International Classification of Headache Disorders (version 2) diagnostic criteria for
chronic post-traumatic headaches attributed to mild head injury:
1. Headaches beginning within 1 week of mild traumatic head injury.
2. Headaches persisting > 3 months after head trauma.
3. Head trauma with all of the following:
- no loss of consciousness or loss of consciousness < 30 minutes
- Glasgow Coma Score (GCS) 13-15
- symptoms or signs diagnostic of concussion
1. Patient has another headache disorder not attributable to head trauma which accounts
for at least half of the patient's headache episodes.
2. Patient is currently taking propranolol, amitriptyline, or topiramate for any reason.
3. Patient previously tried propranolol, amitriptyline, or topiramate for headache
4. Patient started a new treatment for headache prevention within the last 6 weeks.
Prophylactic treatments initiated prior to 6 weeks ago are allowed as long as the
dose or regimen is stable. Medications for aborting acute headaches are also
5. Patient previously tried more than two medications for headache prevention.
6. Patient is using narcotic analgesics on average more than 10 days a month.
7. Patient has a medical condition or is taking a medication that is considered a
contraindication for propranolol, topiramate, or amitriptyline. Medical conditions
include liver disease, renal impairment, cardiac dysrhythmias, untreated thyroid
disease, orthostatic hypotension, asthma requiring treatment with inhalers, glaucoma,
kidney stones, insulin-requiring diabetes, or pregnancy.
8. Patient has known hepatic, renal, or cardiac disorders.
9. Patient drinks on average more than two servings of alcohol (2 oz hard liquor, 5 oz
wine, 12 oz beer) per day or more than 3 servings at one time on a weekly basis.
10. Patient has abnormalities on baseline EKG.
11. Patient has major depression defined as a score >15 on the Patient Health
12. Patient is pregnant, planning to become pregnant in the next year, or is a female of
reproductive potential who is not using a reliable form of birth control.
13. Patient has cognitive impairment defined as mini-mental status exam score <27.
14. SBP < 90, HR < 50, or HR > 100.
Locations and Contacts
Madigan Army Medical Center, Tacoma, Washington 98431, United States
Starting date: June 2008
Last updated: April 22, 2013