A Randomized, Double-blind, Placebo-controlled, Crossover Trial of Rizatriptan 10 mg Oral Disintegrating Tablet for Treatment of Acute Attacks of Chronic, Blast-induced, Post-traumatic Headache in U.S. Military Troops

Henry M. Jackson Foundation for the Advancement of Military Medicine1 site in 1 countryFebruary 2011

ConditionsChronic Post-traumatic Headache

InterventionsRizatriptan Placebo

Overview

Phase: Not Applicable
Intervention: Rizatriptan
Conditions: Chronic Post-traumatic Headache
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Locations: 1
Primary Endpoint: Headache Severity
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine the effectiveness of rizatriptan for treating attacks of chronic post-traumatic headache.

Detailed Description

Chronic post-traumatic headaches develop in about one third of soliders who have had head trauma caused by a blast. A wide variety of pain medicines, including rizatriptan, are used to treat these headaches in clinical practice. However, the effectiveness has not been established by clinical research studies.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

August 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Responsible Party

Principal Investigator

Marianne Spevak

Manger, Office of Regulatory Affairs

Henry M. Jackson Foundation for the Advancement of Military Medicine

Eligibility Criteria

Inclusion Criteria

•U.S. Army soldier with history of concussion while deployed to a combat zone. Concussion is defined as head trauma with all of the following:
•No loss of consciousness or loss of consciousness less than 30 minutes.
•Glasgow Coma Score 13-15 (if known)
•Symptoms or signs of concussion.
•Concussion was secondary to primary, secondary, or tertiary blast injury.
•Headaches started within 7 days of concussion.
•Headaches have occurred for more than 3 months but not more than 24 months since the precipitating concussion.
•Headaches occurred 3 to 14 days per month during each of the previous two months.
•Headaches are migraine type and possess three or more of the following migraine features:
•moderate or severe pain

Exclusion Criteria

•Patients with a history of migraine headaches prior to concussion will be excluded.
•Prior use of any triptan medication for headache.
•Use of non-opioid analgesic medications 15 or more days per month for the previous month.
•Use of opioid medications more than 10 days in the previous month.
•Alcohol consumption of more than two servings (a serving is 2 oz hard liquor, 5 oz wine, or 12 oz beer) per day or more than 3 servings at one time on a weekly basis.
•Taking two or more medications from the following medication classes: SSRI, SNRI, or TCA.
•Headache prophylactic medication is allowed but must remain unchanged during the study period.
•Patients with depression, defined as a PHQ-9 score greater than 15, will be excluded from study participation.
•PTSD is NOT an exclusion criterion. PTSD will be defined as a clinical diagnosis by a behavioral health provider or PTSD symptom checklist score of 50 or higher.
•Systolic BP \> 140 or diastolic BP \> 90 on repeated measurements.