Clinical trial NCT00293657: Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Headache (Migraine)
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Neurology
state: Alabama
city: Little Rock
country: United States
facility: Little Rock Family Practice Clinic
state: Arkansas
city: Newport Beach
country: United States
facility: C. Phillip O'Carroll, MD, Inc.
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Stamford
country: United States
facility: New England Center for Headache
state: Connecticut
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: North Dartmouth
country: United States
facility: NE Medical Research Associates, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Springfield
country: United States
facility: Headache Care Center
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Reserach / Ryan Headache Center
state: Missouri
city: Chapel Hill
country: United States
facility: University Headache Center
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Houston
country: United States
facility: Houston Headache Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Alexandria
country: United States
facility: The Innovative Clinical Research Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Pain Center
state: Washington
Study officials:
affiliation: Headache Wellness Center
name: James Adelman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Pain Center
name: Sheena Aurora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Institute
name: Gary Berman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Headache Care Center
name: Roger Cady, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diamond Headache Clinic
name: Merle Diamond, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meridien Research
name: Mildred Farmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alabama Clinical Therapeutics
name: Gregory Flippo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Headache Center
name: Kevin Kahn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Medical Clinic for Headache
name: David Kudrow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Carolina Clinical Research
name: Craig LaForce, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Houston Headache Clinic
name: Ninan Mathew, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NE Medical Research Associates, Inc.
name: S. David Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: C. Phillip O'Carroll, MD, Inc.
name: C. Phillip O'Carroll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jean Brown Research
name: Gilbert Podolsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Little Rock Family Practice Clinic
name: Kevin Roberts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Alabama Neurology
name: John Rothrock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Head Pain and Neurological Institute
name: Todd Rozen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Associates, Inc.
name: Stephan Sharp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Center for Headache
name: Fred Sheftell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jefferson Headache Center
name: Stephen Silberstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Health Research / Ryan Headache Center
name: Timothy Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Innovative Clinical Research Center
name: Stuart Stark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Premiere Research Institute
name: Paul Winner, DO
role: PRINCIPAL_INVESTIGATOR
References: