Headache (Migraine)Phase 2NCT00293657
Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
A Phase 2 study testing Lornoxicam 8 mg and Lornoxicam 16 mg in people with Headache (Migraine), run by POZEN at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache (Migraine)
- What is being tested?
- Lornoxicam 8 mg and Lornoxicam 16 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 23 sitesUnited States
- Study dates
- Dec 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
The Innovative Clinical Research Center
Alexandria, Virginia, 22304
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
University Headache Center
Chapel Hill, North Carolina, 27599
Diamond Headache Clinic
Chicago, Illinois, 60614
Headache Wellness Center
Greensboro, North Carolina, 27401
Houston Headache Clinic
Houston, Texas, 77004
Little Rock Family Practice Clinic
Little Rock, Arkansas, 72205
University of South Alabama Neurology
Mobile, Alabama, 36693
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
C. Phillip O'Carroll, MD, Inc.
Newport Beach, California, 92660
NE Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Clinical Research Institute
Plymouth, Minnesota, 55441
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Jean Brown Research
Salt Lake City, Utah, 84124
California Medical Clinic for Headache
Santa Monica, California, 90404
Swedish Pain Center
Seattle, Washington, 98104
Headache Care Center
Springfield, Missouri, 65807
Mercy Health Reserach / Ryan Headache Center
St Louis, Missouri, 63141
Meridien Research
St. Petersburg, Florida, 33709
New England Center for Headache
Stamford, Connecticut, 06902
Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
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.
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.
Read the 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.
- Conditions
- Headache (Migraine)
- Being tested
- Lornoxicam 8 mg, Lornoxicam 16 mg, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lornoxicam 8 mgDrug
Lornoxicam 16 mgDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache (Migraine)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- POZEN
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Adelman, MD, Principal investigator, Headache Wellness CenterSheena Aurora, MD, Principal investigator, Swedish Pain CenterGary Berman, MD, Principal investigator, Clinical Research InstituteRoger Cady, MD, Principal investigator, Headache Care CenterMerle Diamond, MD, Principal investigator, Diamond Headache ClinicMildred Farmer, MD, Principal investigator, Meridien ResearchGregory Flippo, MD, Principal investigator, Alabama Clinical TherapeuticsKevin Kahn, MD, Principal investigator, University Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293657
- Sponsor's protocol ID
- LNP-201
- Status last verified
- Nov 2012
- First submitted
- 15 Feb 2006
- Last updated
- 3 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00293657
- Acronym / sponsor ID
- LNP-201
- Conditions
- Headache (Migraine)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- POZENIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lornoxicam 8 mg | Drug | – |
| Lornoxicam 16 mg | Drug | – |
| Placebo | Drug | – |
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).
1 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Adelman, MD principal investigator
Headache Wellness Center
Sheena Aurora, MD principal investigator
Swedish Pain Center
Gary Berman, MD principal investigator
Clinical Research Institute
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lornoxicam 8 mg and Lornoxicam 16 mg in people with Headache (Migraine), run by POZEN at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.