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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 Development Command
Information provided by (Responsible Party):
Jay C. Erickson, Madigan Army Medical Center

Tracking Information
First Submitted Date  ICMJE March 12, 2009
First Posted Date  ICMJE March 16, 2009
Last Update Posted Date April 23, 2013
Study Start Date  ICMJE June 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2009)
Headache days per month on the third month of treatment [ Time Frame: Monthly for 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical Therapies for Chronic Post-Traumatic Headaches
Official Title  ICMJE A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Headache
Intervention  ICMJE
  • Drug: Placebo
    Every month for 3 months
  • Drug: Propranolol
    target does 80 mg per day for 3 months
    Other Name: Inderal
  • Drug: Amitriptyline
    Target does of 50 mg per day for 3 months
    Other Name: Elavil
  • Drug: Topiramate
    Target dose 100 mg a day for 3 months
    Other Name: Topamax
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo group
    Intervention: Drug: Placebo
  • Experimental: Propranolol
    Propranolol (target dose 80 mg a day)
    Intervention: Drug: Propranolol
  • Experimental: Topiramate
    Topiramate (target dose 100 mg a day)
    Intervention: Drug: Topiramate
  • Experimental: Amitriptyline
    Amitriptyline (target dose 50 mg a day)
    Intervention: Drug: Amitriptyline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 22, 2013)
64
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2009)
240
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862095
Other Study ID Numbers  ICMJE 208075
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jay C. Erickson, Madigan Army Medical Center
Study Sponsor  ICMJE Madigan Army Medical Center
Collaborators  ICMJE U.S. Army Medical Research and Development Command
Investigators  ICMJE
Principal Investigator: Jay Erickson, MD Madigan Army Medical Center
PRS Account Madigan Army Medical Center
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP