Study of Rizatriptan in the Treatment of Acute Attacks of Post-traumatic Headache in U.S. Military Troops (Maxalt)
Verified August 2013 by Henry M. Jackson Foundation for the Advancement of Military Medicine
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marianne Spevak, Henry M. Jackson Foundation for the Advancement of Military Medicine
First received: February 25, 2011
Last updated: August 26, 2013
Last verified: August 2013
The purpose of the study is to determine the effectiveness of rizatriptan for treating attacks of chronic post-traumatic headache.
Chronic Post-traumatic Headache
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- 24 hour Migraine Quality of Life score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
Active Comparator: rizatriptan
initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo
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
Other Name: Maxalt
Placebo Comparator: Placebo
Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg
Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.
Other Name: sugar pill
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.
|Ages Eligible for Study:
||18 Years to 49 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306266
|Madigan Army Medical Center - Neurology Clinic
|Tacoma, Washington, United States, 98431 |
|Sub-Investigator: Sarah K Gibbons, DO |
|Sub-Investigator: Dean Kao, PA-C |
Henry M. Jackson Foundation for the Advancement of Military Medicine
Merck Sharp & Dohme Corp.
||Jay C Erickson, MD
||U.S. Army Medical Corp. Madigan Army Medical Center
No publications provided
||Marianne Spevak, Manger, Office of Regulatory Affairs, Henry M. Jackson Foundation for the Advancement of Military Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 25, 2011
||August 26, 2013
||United States: Institutional Review Board
United States: Federal Government
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Central Nervous System Diseases
Headache Disorders, Primary
Serotonin Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs