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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Assessment of headache pain intensity over 24 hours after treatment, rated on a categorical scale of 0-3 and a visual analog scale (VAS).
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of South Alabama Neurology
Mobile, Alabama, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, United States
C. Phillip O'Carroll, MD, Inc.
Newport Beach, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
New England Center for Headache
Stamford, Connecticut, United States
Meridien Research
St. Petersburg, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
NE Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States
...and 13 more locations