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.
Drug: Lornoxicam 8 mg
Drug: Lornoxicam 16 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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.|
- 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.
|Study Start Date:||December 2005|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
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.
Show 23 Study Locations
|Principal Investigator:||James Adelman, MD||Headache Wellness Center|
|Principal Investigator:||Sheena Aurora, MD||Swedish Pain Center|
|Principal Investigator:||Gary Berman, MD||Clinical Research Institute|
|Principal Investigator:||Roger Cady, MD||Headache Care Center|
|Principal Investigator:||Merle Diamond, MD||Diamond Headache Clinic|
|Principal Investigator:||Mildred Farmer, MD||Meridien Research|
|Principal Investigator:||Gregory Flippo, MD||Alabama Clinical Therapeutics|
|Principal Investigator:||Kevin Kahn, MD||University Headache Center|
|Principal Investigator:||David Kudrow, MD||California Medical Clinic for Headache|
|Principal Investigator:||Craig LaForce, MD||North Carolina Clinical Research|
|Principal Investigator:||Ninan Mathew, MD||The Houston Headache Clinic|
|Principal Investigator:||S. David Miller, MD||NE Medical Research Associates, Inc.|
|Principal Investigator:||C. Phillip O'Carroll, MD||C. Phillip O'Carroll, MD, Inc.|
|Principal Investigator:||Gilbert Podolsky, MD||Jean Brown Research|
|Principal Investigator:||Kevin Roberts, MD||Little Rock Family Practice Clinic|
|Principal Investigator:||John Rothrock, MD||University of South Alabama Neurology|
|Principal Investigator:||Todd Rozen, MD||Michigan Head Pain and Neurological Institute|
|Principal Investigator:||Stephan Sharp, MD||Clinical Research Associates, Inc.|
|Principal Investigator:||Fred Sheftell, MD||New England Center for Headache|
|Principal Investigator:||Stephen Silberstein, MD||Jefferson Headache Center|
|Principal Investigator:||Timothy Smith, MD||Mercy Health Research / Ryan Headache Center|
|Principal Investigator:||Stuart Stark, MD||The Innovative Clinical Research Center|
|Principal Investigator:||Paul Winner, DO||Premiere Research Institute|