Clinical Trial: Study of Rizatriptan in the Treatment of Acute Attacks of Post-traumatic Headache in U.S. Military Troops

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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-tra

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

Detailed Summary: 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.
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Current Primary Outcome: Headache Severity [ Time Frame: 2 hours ]

proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing


Original Primary Outcome: Same as current

Current Secondary Outcome: 24 hour Migraine Quality of Life score [ Time Frame: 24 hours ]

proportions of subjects achieving complete headache relief at 2 hours, sustained headache relief at 24 hours, 24-hour Migraine Quality of Life score, disability 2 hours after dosing, occurrence of associated symptoms, and side effects.


Original Secondary Outcome: Same as current

Information By: Henry M. Jackson Foundation for the Advancement of Military Medicine

Dates:
Date Received: February 25, 2011
Date Started: February 2011
Date Completion: August 2011
Last Updated: August 17, 2015
Last Verified: August 2015