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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of the study is to determine the effectiveness of rizatriptan for treating attacks of chronic post-traumatic headache.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rizatriptan | Active Comparator | initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo |
|
| Placebo | Placebo Comparator | Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rizatriptan | Drug | 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 |
|
| 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 |
| 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 |
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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.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay C Erickson, MD | U.S. Army Medical Corp. Madigan Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center - Neurology Clinic | Tacoma | Washington | 98431 | United States |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C093622 | rizatriptan |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Placebo | Drug | Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache. |
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