Study of Rizatriptan in the Treatment of Acute Attacks of Post-traumatic Headache in U.S. Militar… (NCT01306266) | Clinical Trial Compass
WithdrawnNot Applicable
Study of Rizatriptan in the Treatment of Acute Attacks of Post-traumatic Headache in U.S. Military Troops
United States0Started 2011-02
Plain-language summary
The purpose of the study is to determine the effectiveness of rizatriptan for treating attacks of chronic post-traumatic headache.
Who can participate
Age range
18 Years – 49 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion criteria
. Patients with a history of migraine headaches prior to concussion will be excluded.
. Prior use of any triptan medication for headache.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial was withdrawn before enrolling anyone, can you tell me why it was cancelled and whether there are any similar studies on rizatriptan for post-traumatic headache that I could look into instead?
2This study was specifically focused on U.S. military personnel with chronic post-traumatic headache — does my particular history and background mean I might still be a good candidate for a related study, or would a different treatment path make more sense for me?
3Rizatriptan is already used for migraines, so given that this trial never completed, is there any existing evidence my doctor thinks is strong enough to consider prescribing it off-label for my post-traumatic headaches?
4Because this trial was withdrawn and never generated results on headache severity, what does my doctor think is currently the best-supported treatment option for chronic post-traumatic headache in my situation?
5Are there any currently recruiting trials studying treatments for chronic post-traumatic headache that my doctor would recommend I look into as an alternative to this withdrawn study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Headache Severity
Timeframe: 2 hours
Trial details
NCT IDNCT01306266
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
. 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.