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

NCT01306266 | Withdrawn

• 1 other identifier: MAMC 211004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Post-traumatic Headache

Keywords

active duty; blast induced; headache

Outcome Measures

Primary Outcomes (1)

• Headache Severity

  proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing

  2 hours

Secondary Outcomes (1)

• 24 hour Migraine Quality of Life score

  24 hours

Study Arms (2)

rizatriptan

ACTIVE COMPARATOR

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

Drug: Rizatriptan

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rizatriptan 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

Also known as: Maxalt

rizatriptan

Placebo DRUG

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

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Madigan Army Medical Center - Neurology Clinic

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Headache

Interventions

rizatriptan; Sugars

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Jay C Erickson, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manger, Office of Regulatory Affairs

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 1, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 18, 2015

Record last verified: 2015-08

Locations

US (1)