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| 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 |
| 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
|
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 |
Inclusion criteria:
International Classification of Headache Disorders (version 2) diagnostic criteria for chronic post-traumatic headaches attributed to mild head injury:
Head trauma with all of the following:
Exclusion criteria:
Contacts and Locations| Contact: Jay Erickson, MD | 253-968-1440 | jay.erickson@us.army.mil |
| United States, Washington | |
| Madigan Army Medical Center | Recruiting |
| Tacoma, Washington, United States, 98431 | |
| Principal Investigator: Jay Erickson, MD | |
| Principal Investigator: | Jay Erickson, MD | Madigan Army Medical Center |
More Information
| 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 |
|
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 |