Medical Therapies for Chronic Post-Traumatic Headaches

This study has been terminated.
(inadequate enrollment, insufficient funds to continue enrollment)
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Jay C. Erickson, Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT00862095
First received: March 12, 2009
Last updated: April 22, 2013
Last verified: April 2013
  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 4

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

Enrollment: 64
Study Start Date: June 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862095

Locations
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
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: Jay C. Erickson, Chief, Neurology Service, Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT00862095     History of Changes
Other Study ID Numbers: 208075
Study First Received: March 12, 2009
Last Updated: April 22, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Amitriptyline
Propranolol
Amitriptyline, perphenazine drug combination
Topiramate
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014