Expired Study
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Tacoma, Washington 98431


Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

MAMC 211004


NCT ID:

NCT01306266


Secondary ID:


Study Acronym:

Maxalt


Brief Title:

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


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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

49 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Henry M. Jackson Foundation for the Advancement of Military Medicine


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jay C Erickson, MD
Principal Investigator
U.S. Army Medical Corp. Madigan Army Medical Center

Study Dates

Start Date:February 2011
Completion Date:August 2011
Completion Type:Anticipated
Primary Completion Date:August 2011
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:August 17, 2015
First Received Date:February 25, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:24 hour Migraine Quality of Life score
Time Frame:24 hours
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Headache Severity
Time Frame:2 hours
Safety Issues:False
Description:proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.
Arm Name:Placebo
Other Name:sugar pill
Intervention Type:Drug
Name:Rizatriptan
Description: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
Arm Name:rizatriptan
Other Name:Maxalt

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg
Study Arm Type:Active Comparator
Arm Name:rizatriptan
Description:initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Henry M. Jackson Foundation for the Advancement of Military Medicine
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck Sharp & Dohme Corp.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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