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