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Medical Therapies for Chronic Post-Traumatic Headaches

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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
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Jay C. Erickson, Madigan Army Medical Center

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

Condition or disease Intervention/treatment Phase
Headache Drug: Placebo Drug: Propranolol Drug: Amitriptyline Drug: Topiramate Phase 4

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.


Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Headache days per month on the third month of treatment [ Time Frame: Monthly for 4 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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
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Responsible Party: Jay C. Erickson, Chief, Neurology Service, Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT00862095     History of Changes
Other Study ID Numbers: 208075
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

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
Propranolol
Amitriptyline
Topiramate
 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
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents
Antidepressive Agents, Tricyclic