Medical Therapies for Chronic Post-Traumatic Headaches
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00862095 |
Recruitment Status :
Terminated
(inadequate enrollment, insufficient funds to continue enrollment)
First Posted : March 16, 2009
Last Update Posted : April 23, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Headache | Drug: Placebo Drug: Propranolol Drug: Amitriptyline Drug: Topiramate | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo group
|
Drug: Placebo
Every month for 3 months |
Experimental: Propranolol
Propranolol (target dose 80 mg a day)
|
Drug: Propranolol
target does 80 mg per day for 3 months
Other Name: Inderal |
Experimental: Topiramate
Topiramate (target dose 100 mg a day)
|
Drug: Topiramate
Target dose 100 mg a day for 3 months
Other Name: Topamax |
Experimental: Amitriptyline
Amitriptyline (target dose 50 mg a day)
|
Drug: Amitriptyline
Target does of 50 mg per day for 3 months
Other Name: Elavil |
- Headache days per month on the third month of treatment [ Time Frame: Monthly for 4 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862095
United States, Washington | |
Madigan Army Medical Center | |
Tacoma, Washington, United States, 98431 |
Principal Investigator: | Jay Erickson, MD | Madigan Army Medical Center |
Responsible Party: | Jay C. Erickson, Chief, Neurology Service, Madigan Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00862095 |
Other Study ID Numbers: |
208075 |
First Posted: | March 16, 2009 Key Record Dates |
Last Update Posted: | April 23, 2013 |
Last Verified: | April 2013 |
Post-Traumatic Headache Headache Pain Neurologic Manifestations Headache Disorders, Secondary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Topiramate Propranolol Amitriptyline Amitriptyline, perphenazine drug combination Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents Anticonvulsants Hypoglycemic Agents Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |