Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Headache (Migraine)	Drug: Lornoxicam 8 mg Drug: Lornoxicam 16 mg Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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.

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by POZEN:

Primary Outcome Measures:

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:

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.


Estimated Enrollment:	150
Study Start Date:	December 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

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


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293657

Show 23 Study Locations

Sponsors and Collaborators

POZEN

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00293657 History of Changes
Other Study ID Numbers:	LNP-201
Study First Received:	February 15, 2006
Last Updated:	November 29, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Lornoxicam Piroxicam	Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016