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

This study is currently recruiting participants.
Verified November 2012 by Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Marianne Spevak, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01306266
First received: February 25, 2011
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Chronic Post-traumatic Headache
 Drug: Rizatriptan
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • Headache Severity [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing


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: 40
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rizatriptan
initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo
 Drug: Rizatriptan
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
 Drug: Placebo
Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.
Other Name: sugar pill

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:
  2. No loss of consciousness or loss of consciousness less than 30 minutes.
  3. Glasgow Coma Score 13-15 (if known)
  4. Symptoms or signs of concussion.
  5. Concussion was secondary to primary, secondary, or tertiary blast injury.
  6. Headaches started within 7 days of concussion.
  7. Headaches have occurred for more than 3 months but not more than 24 months since the precipitating concussion.
  8. Headaches occurred 3 to 14 days per month during each of the previous two months.
  9. Headaches are migraine type and possess three or more of the following migraine features:
  10. moderate or severe pain
  11. throbbing or pulsatile pain
  12. unilateral or asymmetric pain
  13. pain exacerbated by or interfering with routine physical activity
  14. nausea or vomiting
  15. photosensitivity and phonosensitivity
  16. Headaches last 4 or more hours without treatment.
  17. Males 18 to 49 years of age.

  18. Migraine Disability Assessment Score (MIDAS) greater than 10 or Headache Impact Test-6 (HIT6) score greater than 60.

    -

Exclusion Criteria:

  1. Patients with a history of migraine headaches prior to concussion will be excluded.
  2. Prior use of any triptan medication for headache.
  3. Use of non-opioid analgesic medications 15 or more days per month for the previous month.
  4. Use of opioid medications more than 10 days in the previous month.
  5. 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.
  6. Taking two or more medications from the following medication classes: SSRI, SNRI, or TCA.
  7. Headache prophylactic medication is allowed but must remain unchanged during the study period.
  8. Patients with depression, defined as a PHQ-9 score greater than 15, will be excluded from study participation.
  9. 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.
  10. Systolic BP > 140 or diastolic BP > 90 on repeated measurements.
  11. Active use of dihydroergotamine.
  12. Known coronary artery disease, prior myocardial infarction, history of stroke or TIA, or liver disease.
  13. Subjects who will not be available for study-related follow-up visits will be excluded.
  14. Patient has cognitive impairment defined as mini-mental status exam score less than 27.
  15. Patients undergoing a medical board for headache, sequelae of TBI, or psychiatric disorders will be excluded.
  16. Patients suspected of malingering, exaggerating symptoms, or non-compliance will be excluded from study participation.
  17. Patient has hemiplegic migraine or basilar migraine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306266

Contacts
Contact: Jay C Erickson, MD 253-968-0494 jay.erickson@us.army.mil

Locations
United States, Washington
Madigan Army Medical Center - Neurology Clinic Recruiting
Tacoma, Washington, United States, 98431
Sub-Investigator: Sarah K Gibbons, DO            
Sub-Investigator: Dean Kao, PA-C            
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Merck
Investigators
Principal Investigator: Jay C Erickson, MD U.S. Army Medical Corp. Madigan Army Medical Center
  More Information

No publications provided

Responsible Party: Marianne Spevak, Manger, Office of Regulatory Affairs, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01306266     History of Changes
Other Study ID Numbers: MAMC 211004
Study First Received: February 25, 2011
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
active duty
blast induced
headache

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Tension-Type Headache
Headache Disorders, Secondary
Headache Disorders
Headache Disorders, Primary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Brain Diseases
Central Nervous System Diseases
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013