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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Post-traumatic Headache

Intervention / Treatment
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* Drug: Rizatriptan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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. - 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rizatriptan<br>initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo | Drug: Rizatriptan<br>* initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo. Drug is to be taken at onset of a moderate or severe headache<br>* Other names: Maxalt;|
| Placebo Comparator: Placebo<br>Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg | Drug: Placebo<br>* Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Severity | proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour Migraine Quality of Life score | 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. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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active duty, blast induced, headache