Medical Therapies for Chronic Post-Traumatic Headaches

NCT ID: NCT00862095

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-04-30

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Every month for 3 months

Propranolol

Propranolol (target dose 80 mg a day)

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

target does 80 mg per day for 3 months

Topiramate

Topiramate (target dose 100 mg a day)

Group Type: EXPERIMENTAL

Topiramate

Intervention Type: DRUG

Target dose 100 mg a day for 3 months

Amitriptyline

Amitriptyline (target dose 50 mg a day)

Group Type: EXPERIMENTAL

Amitriptyline

Intervention Type: DRUG

Target does of 50 mg per day for 3 months

Interventions

Placebo

Every month for 3 months

Intervention Type: DRUG

Propranolol

target does 80 mg per day for 3 months

Intervention Type: DRUG

Amitriptyline

Target does of 50 mg per day for 3 months

Intervention Type: DRUG

Topiramate

Target dose 100 mg a day for 3 months

Intervention Type: DRUG

Other Intervention Names

Inderal; Elavil; Topamax

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Madigan Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Jay C. Erickson

Chief, Neurology Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay Erickson, MD

Role: PRINCIPAL_INVESTIGATOR

Madigan Army Medical Center

Locations

Madigan Army Medical Center

Tacoma, Washington, United States

Countries

United States

Other Identifiers

208075

Identifier Type: -

Identifier Source: org_study_id