Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
Information source: Pozen
Information obtained from ClinicalTrials.gov on October 22, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Headache (Migraine)
Intervention: Lornoxicam 8 mg (Drug); Lornoxicam 16 mg (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pozen Official(s) and/or principal investigator(s):
James Adelman, MD, Principal Investigator, Affiliation: Headache Wellness Center
Sheena Aurora, MD, Principal Investigator, Affiliation: Swedish Pain Center
Gary Berman, MD, Principal Investigator, Affiliation: Clinical Research Institute
Roger Cady, MD, Principal Investigator, Affiliation: Headache Care Center
Merle Diamond, MD, Principal Investigator, Affiliation: Diamond Headache Clinic
Mildred Farmer, MD, Principal Investigator, Affiliation: Meridien Research
Gregory Flippo, MD, Principal Investigator, Affiliation: Alabama Clinical Therapeutics
Kevin Kahn, MD, Principal Investigator, Affiliation: University Headache Center
David Kudrow, MD, Principal Investigator, Affiliation: California Medical Clinic for Headache
Craig LaForce, MD, Principal Investigator, Affiliation: North Carolina Clinical Research
Ninan Mathew, MD, Principal Investigator, Affiliation: The Houston Headache Clinic
S. David Miller, MD, Principal Investigator, Affiliation: NE Medical Research Associates, Inc.
C. Phillip O'Carroll, MD, Principal Investigator, Affiliation: C. Phillip O'Carroll, MD, Inc.
Gilbert Podolsky, MD, Principal Investigator, Affiliation: Jean Brown Research
Kevin Roberts, MD, Principal Investigator, Affiliation: Little Rock Family Practice Clinic
John Rothrock, MD, Principal Investigator, Affiliation: University of South Alabama Neurology
Todd Rozen, MD, Principal Investigator, Affiliation: Michigan Head Pain and Neurological Institute
Stephan Sharp, MD, Principal Investigator, Affiliation: Clinical Research Associates, Inc.
Fred Sheftell, MD, Principal Investigator, Affiliation: New England Center for Headache
Stephen Silberstein, MD, Principal Investigator, Affiliation: Jefferson Headache Center
Timothy Smith, MD, Principal Investigator, Affiliation: Mercy Health Research / Ryan Headache Center
Stuart Stark, MD, Principal Investigator, Affiliation: The Innovative Clinical Research Center
Paul Winner, DO, Principal Investigator, Affiliation: Premiere Research Institute
Summary
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.
Clinical Details
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.
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States
University of South Alabama Neurology, Mobile, Alabama 36693, United States
Little Rock Family Practice Clinic, Little Rock, Arkansas 72205, United States
California Medical Clinic for Headache, Santa Monica, California 90404, United States
C. Phillip O'Carroll, MD, Inc., Newport Beach, California 92660, United States
New England Center for Headache, Stamford, Connecticut 06902, United States
Meridien Research, St. Petersburg, Florida 33709, United States
Premiere Research Institute, West Palm Beach, Florida 33407, United States
Diamond Headache Clinic, Chicago, Illinois 60614, United States
NE Medical Research Associates, Inc., North Dartmouth, Massachusetts 02747, United States
Michigan Head Pain and Neurological Institute, Ann Arbor, Michigan 48104, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
Headache Care Center, Springfield, Missouri 65807, United States
Mercy Health Reserach / Ryan Headache Center, St. Louis, Missouri 63141, United States
Headache Wellness Center, Greensboro, North Carolina 27401, United States
University Headache Center, Chapel Hill, North Carolina 27599, United States
North Carolina Clinical Research, Raleigh, North Carolina 27607, United States
Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States
Clinical Research Associates, Inc., Nashville, Tennessee 37203, United States
Houston Headache Clinic, Houston, Texas 77004, United States
Jean Brown Research, Salt Lake City, Utah 84124, United States
The Innovative Clinical Research Center, Alexandria, Virginia 22304, United States
Swedish Pain Center, Seattle, Washington 98104, United States
Additional Information
Starting date:
December 2005
Last updated: April 18, 2006
|
