Medical Therapies for Chronic Post-Traumatic Headaches

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Headache

In brief

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

Key facts

Study ID

NCT00862095

Run by

Madigan Army Medical Center

People needed

64

Starts

2008-06-01

Expected to finish

2013-04-01

Last updated by the study team

2013-04-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient meets ICHD criteria for chronic post-traumatic headaches (see below).
• Patient is 18-50 years old.
• Patient has experienced 6 or more days of headache per month for each of the last 2 months.
• Patient has full capacity to provide informed consent.
• Patient will be available for all study-related visits over the next 4 months.
• 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:
• Headaches beginning within 1 week of mild traumatic head injury.
• Headaches persisting > 3 months after head trauma.
• 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

You may not qualify if…

• Patient has another headache disorder not attributable to head trauma which accounts for at least half of the patient's headache episodes.
• Patient is currently taking propranolol, amitriptyline, or topiramate for any reason.
• Patient previously tried propranolol, amitriptyline, or topiramate for headache treatment.
• 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 allowed.
• Patient previously tried more than two medications for headache prevention.
• Patient is using narcotic analgesics on average more than 10 days a month.
• 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.
• Patient has known hepatic, renal, or cardiac disorders.
• 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.
• Patient has abnormalities on baseline EKG.
• Patient has major depression defined as a score >15 on the Patient Health Questionnaire-9.
• 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.
• Patient has cognitive impairment defined as mini-mental status exam score <27.
• SBP < 90, HR < 50, or HR > 100.

Where it is running

• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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