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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Chronic Post-traumatic Headache

In brief

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

Key facts

Study ID

NCT01306266

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

0

Starts

2011-02-01

Expected to finish

2011-08-01

Last updated by the study team

2015-08-18

Who can join

Age: 18 and older, up to 49. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• throbbing or pulsatile pain
• unilateral or asymmetric pain
• pain exacerbated by or interfering with routine physical activity
• nausea or vomiting
• photosensitivity and phonosensitivity
• Headaches last 4 or more hours without treatment.
• Males 18 to 49 years of age.
• Migraine Disability Assessment Score (MIDAS) greater than 10 or Headache Impact Test-6 (HIT6) score greater than 60.

You may not qualify if…

• 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.
• Active use of dihydroergotamine.
• Known coronary artery disease, prior myocardial infarction, history of stroke or TIA, or liver disease.
• Subjects who will not be available for study-related follow-up visits will be excluded.
• Patient has cognitive impairment defined as mini-mental status exam score less than 27.
• Patients undergoing a medical board for headache, sequelae of TBI, or psychiatric disorders will be excluded.
• Patients suspected of malingering, exaggerating symptoms, or non-compliance will be excluded from study participation.
• Patient has hemiplegic migraine or basilar migraine.

Where it is running

• Madigan Army Medical Center - Neurology Clinic — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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