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Medical Therapies for Chronic Post-Traumatic Headaches
This study is currently recruiting participants.
Verified by Madigan Army Medical Center, March 2009
First Received: March 12, 2009   Last Updated: March 13, 2009   History of Changes
Sponsor: Madigan Army Medical Center
Collaborator: U.S. Army Medical Research and Materiel Command
Information provided by: Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT00862095
  Purpose

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


Condition Intervention Phase
Headache
Drug: Placebo
Drug: Propranolol
Drug: Amitriptyline
Drug: Topiramate
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study
Official Title: A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

Resource links provided by NLM:


Further study details as provided by Madigan Army Medical Center:

Primary Outcome Measures:
  • Headache days per month on the third month of treatment [ Time Frame: Monthly for 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: June 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator
Placebo group
Drug: Placebo
Every month for 3 months
Propranolol: Experimental
Propranolol (target dose 80 mg a day)
Drug: Propranolol
target does 80 mg per day for 3 months
Topiramate: Experimental
Topiramate (target dose 100 mg a day)
Drug: Topiramate
Target dose 100 mg a day for 3 months
Amitriptyline: Experimental
Amitriptyline (target dose 50 mg a day)
Drug: Amitriptyline
Target does of 50 mg per day for 3 months

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862095

Contacts
Contact: Jay Erickson, MD 253-968-1440 jay.erickson@us.army.mil

Locations
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Principal Investigator: Jay Erickson, MD            
Sponsors and Collaborators
Madigan Army Medical Center
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Jay Erickson, MD Madigan Army Medical Center
  More Information

No publications provided

Responsible Party: Neurology Service, Madigan Army Medical Center ( Jay Erickson, MD )
Study ID Numbers: 208075
Study First Received: March 12, 2009
Last Updated: March 13, 2009
ClinicalTrials.gov Identifier: NCT00862095     History of Changes
Health Authority: United States: Federal Government;   United States: Institutional Review Board

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Post-Traumatic Headache
Headache Disorders, Primary
Pain
Brain Diseases
Neuroprotective Agents
Headache Disorders
Signs and Symptoms
Propranolol
Sensory System Agents
Therapeutic Uses
Headache
Adrenergic beta-Antagonists
Topiramate
Anti-Arrhythmia Agents
Analgesics
Antidepressive Agents
Tension-Type Headache
Nervous System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Antihypertensive Agents
Protective Agents

ClinicalTrials.gov processed this record on February 08, 2010