Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.

Study Overview
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Brief Summary
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To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for the acute treatment of moderate or severe headache associated with a single migraine attack in patients with a history of migraine. Two-thirds of patients in this study will receive a single dose of intravenous lornoxicam (8mg or 16 mg) and one-third of patients will receive a single dose of an intravenous placebo.

Detailed Description
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The headache of migraine is the primary symptom of this disorder that is estimated to affect approximately 10% of the population of developed countries, with the majority of persons with migraine being females between the ages of 20 and 50 years. Patients with migraine desire rapid and complete relief from headache and decreased frequency of recurrence over the 24 hours after treatment. Current treatments for migraine often provide incomplete pain relief and additional acute treatments are needed. Lornoxicam is a member of the NSAID class of anti-inflammatory drugs and is shown to be effective in the acute management of postoperative pain and arthritis. The current study will evaluate the efficacy of single doses of lornoxicam, administered intravenously, in treatment of the headache of migraine to determine possible future uses of this drug in this condition.

Official Title
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A Randomized, Double-Blind, Single-Dose Study, Placebo-Controlled Evaluation of the Safety and Efficacy of Intravenous Lornoxicam in the Acute Treatment of the Headache of Migraine.

Conditions
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Headache (Migraine)

Intervention / Treatment
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* Drug: Lornoxicam 8 mg
* Drug: Lornoxicam 16 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have a demonstrated history of migraine headaches according to the International Headache Society (IHS) criteria 1.1 or 1.2 (2004), had their first migraine prior to age 50, and have had an average migraine headache frequency of 2-6 migraines per month, of moderate or severe pain intensity, in each of the last 6 months prior to screening. Subjects are willing to come to the study site when he/she has onset of the headache of migraine to receive an intravenous dose of study medication and is willing to remain in the investigator's clinic for at least 2 hours after the intravenous dose for collection of study data (Subject is discharged to home after 2 hour post-dose evaluations are completed). Exclusion Criteria: Subjects who are pregnant. Subjects has known allergic reactions or intolerance to NSAIDs; any subject in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the symptoms of asthma, rhinitis and nasal polyps. Subject is receiving any medications known or suspected to have drug interactions with lornoxicam. These include: warfarin or other anticoagulants, digoxin, probenecid, methotrexate, lithium, aspirin, cimetidine, cyclosporine and/or furosemide. Subjects with a non-migraine (i.e., tension-type, sinus, etc.) headache frequency of >15 days/month in each of the 3 months (90 days) prior to screening. Subjects experiencing greater than an average of 6 migraine attacks per month and/or >15 migraine days per month in the 6 months prior to screening. Subjects with a history of documented gastrointestinal ulceration in the past six months or hospitalization for gastrointestinal bleeding in the past year. Subjects with history of impaired renal function and/or a history of kidney disease, interstitial nephritis, nephrotic syndrome, and/or peripheral edema. Subjects with history of heart disease or certain related conditions. Subjects with uncontrolled hypertension or hypertension that is difficult to control with medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lornoxicam 8 mg|nan|
|Drug: Lornoxicam 16 mg|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of headache pain intensity over 24 hours after treatment, rated on a categorical scale of 0-3 and a visual analog scale (VAS). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of symptoms of photophobia, phonophobia, nausea and vomiting, rated as present or absent; use of rescue medication in the 24 hours after dosing; response of allodynia symptoms present at time of treatment. |  |  |