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Medical Therapies for Chronic Post-Traumatic Headaches

Primary Purpose

Headache

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Propranolol
Amitriptyline
Topiramate
Sponsored by
Madigan Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Propranolol

Topiramate

Amitriptyline

Arm Description

Placebo group

Propranolol (target dose 80 mg a day)

Topiramate (target dose 100 mg a day)

Amitriptyline (target dose 50 mg a day)

Outcomes

Primary Outcome Measures

Headache days per month on the third month of treatment

Secondary Outcome Measures

Full Information

First Posted
March 12, 2009
Last Updated
April 22, 2013
Sponsor
Madigan Army Medical Center
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT00862095
Brief Title
Medical Therapies for Chronic Post-Traumatic Headaches
Official Title
A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
inadequate enrollment, insufficient funds to continue enrollment
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Madigan Army Medical Center
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group
Arm Title
Propranolol
Arm Type
Experimental
Arm Description
Propranolol (target dose 80 mg a day)
Arm Title
Topiramate
Arm Type
Experimental
Arm Description
Topiramate (target dose 100 mg a day)
Arm Title
Amitriptyline
Arm Type
Experimental
Arm Description
Amitriptyline (target dose 50 mg a day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Every month for 3 months
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Inderal
Intervention Description
target does 80 mg per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Other Intervention Name(s)
Elavil
Intervention Description
Target does of 50 mg per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax
Intervention Description
Target dose 100 mg a day for 3 months
Primary Outcome Measure Information:
Title
Headache days per month on the third month of treatment
Time Frame
Monthly for 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Erickson, MD
Organizational Affiliation
Madigan Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

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Medical Therapies for Chronic Post-Traumatic Headaches

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