Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2025-12-24 @ 2:21 PM
NCT ID:
NCT00862095
Eligibility Criteria:
Inclusion criteria:
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 months.
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
Exclusion criteria:
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 treatment.
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 allowed.
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 Questionnaire-9.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00862095
Study Brief:
Protocol Section:
NCT00862095