Medical Therapies for Chronic Post-Traumatic Headaches

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00862095
• Other study ID #: 208075
• Status: Terminated
• Phase: Phase 4
• First received: March 12, 2009
• Last updated: April 22, 2013
• Start date: June 2008
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Madigan Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache
• Tension-Type Headache

Intervention

Drug:
• Placebo
Every month for 3 months
• Propranolol
target does 80 mg per day for 3 months
• Amitriptyline
Target does of 50 mg per day for 3 months
• Topiramate
Target dose 100 mg a day for 3 months

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Madigan Army Medical Center	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache days per month on the third month of treatment		Monthly for 4 weeks	No