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

Chronic Post-traumatic Headache Clinical Trial

— Maxalt  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01306266
• Other study ID #: MAMC 211004
• Status: Withdrawn
• Phase: N/A
• First received: February 25, 2011
• Last updated: August 17, 2015
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: August 2015
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Post-traumatic Headache
• Headache
• Post-Traumatic Headache
• Tension-Type Headache

Intervention

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

Locations

Country	Name	City	State
United States	Madigan Army Medical Center - Neurology Clinic	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Severity	proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing	2 hours	No
Secondary	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	No