NCT01306266WithdrawnNot Applicable
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
Henry M. Jackson Foundation for the Advancement of Military Medicine1 site in 1 countryStarted: February 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Headache Severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Headaches last 4 or more hours without treatment.
- •Males 18 to 49 years of age.
- •Migraine Disability Assessment Score (MIDAS) greater than 10 or Headache Impact Test-6 (HIT6) score greater than
Exclusion Criteria
- •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.
- •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.
- •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
- •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.
- •Patient has hemiplegic migraine or basilar migraine.
Arms & Interventions
rizatriptan
Active Comparator
initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo
Intervention: Rizatriptan (Drug)
Placebo
Placebo Comparator
Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Headache Severity
Time Frame: 2 hours
proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing
Secondary Outcomes
- 24 hour Migraine Quality of Life score(24 hours)
Investigators
Marianne Spevak
Manger, Office of Regulatory Affairs
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study Sites (1)
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