Medical Therapies for Chronic Post-Traumatic Headaches

NCT00862095 | Terminated Phase 4 DMC

• 1 other identifier: 208075
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• Headache days per month on the third month of treatment

  Monthly for 4 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Propranolol

EXPERIMENTAL

Propranolol (target dose 80 mg a day)

Drug: Propranolol

Topiramate

EXPERIMENTAL

Topiramate (target dose 100 mg a day)

Drug: Topiramate

Amitriptyline

EXPERIMENTAL

Amitriptyline (target dose 50 mg a day)

Drug: Amitriptyline

Interventions

Placebo DRUG

Every month for 3 months

Placebo

Propranolol DRUG

target does 80 mg per day for 3 months

Also known as: Inderal

Propranolol

Amitriptyline DRUG

Target does of 50 mg per day for 3 months

Also known as: Elavil

Amitriptyline

Topiramate DRUG

Target dose 100 mg a day for 3 months

Also known as: Topamax

Topiramate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Propranolol; Amitriptyline; Topiramate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Jay Erickson, MD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Neurology Service

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 16, 2009
• Study Start: June 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)