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

NCT ID: NCT01306266

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-08-31

Brief Summary

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

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.

Conditions

Chronic Post-traumatic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rizatriptan

initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo

Group Type: ACTIVE_COMPARATOR

Rizatriptan

Intervention Type: 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

Placebo

Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.

Interventions

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

Intervention Type: DRUG

Placebo

Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.

Intervention Type: DRUG

Other Intervention Names

Maxalt; sugar pill

Eligibility 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.

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Marianne Spevak

Manger, Office of Regulatory Affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay C Erickson, MD

Role: PRINCIPAL_INVESTIGATOR

U.S. Army Medical Corp. Madigan Army Medical Center

Locations

Madigan Army Medical Center - Neurology Clinic

Tacoma, Washington, United States

Countries

United States

Other Identifiers

MAMC 211004

Identifier Type: -

Identifier Source: org_study_id