Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: saline placebo; Ibuprofen
Intervention description: 250 cc of placebo administered IV; 800 mg ibuprofen in 250 cc saline administered IV
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Episodic migraine

Summary:

      This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the
      treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in
      subjects who are treated with study medication between 2 and 72 hours from time of onset of
      headache.

      Periodic safety and efficacy assessments will be performed prior to and after study drug
      administration.

      Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment
      groups (active treatment and placebo) who have pain relief at 2 hours after the completion of
      the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain
      level from severe or moderate decreased to mild or headache-free, respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between the ages of 18 and 65, inclusive

          -  Subject diagnosed with episodic migraine, with or without aura according to ICHD-2
             criteria for at least one-year prior to screening

          -  Subject experiences between 2-10 migraine attacks per month (during the previous 6
             months) with no more than 15 days of headache per month.

          -  Subject is using or agrees to use for the duration of participation a medically
             acceptable form of contraception (as determined by investigator), if female and of
             child-bearing potential

          -  Subject is able to come for 4 hour in-clinic treatment of an acute migraine attack

          -  Subjects are able to understand and comply with all study procedures.

          -  Subject provides written informed consent prior to any screening procedures being
             conducted

          -  If subject is on an allowable migraine preventive medication, the dose has been stable
             for at least 4 weeks prior to screening and the dose will remain stable throughout
             study participation.

        Exclusion Criteria:

          -  Unable to make a reliable self-report of pain intensity to pain relief

          -  Use of analgesic or opioid within 24 hours of onset of headache to be treated with
             study medication. (If subject has an eligible headache and has taken a triptan or DHE
             within 24 hours, but greater than 2 hours before study drug dosing, they can be
             treated with study medication.)

          -  Patients taking the following medications on a regular basis: warfarin, lithium,
             ACE-inhibitors, loop diuretics, thiazide diuretics, ARBs, and methotrexate.

          -  Patients with active, clinically significant anemia

          -  Patients with a history or evidence of asthma

          -  Patients with a history heart failure

          -  Subjects with severely impaired hepatic or renal function, as determined by the
             investigator

          -  Patients with a history of allergy or hypersensitivity to any component of IVIb,
             aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors

          -  Pregnant or nursing women

          -  Patients who have a history of congenital bleeding diathesis (e.g., hemophilia) or any
             active clinically significant bleeding, or have underlying platelet dysfunction
             including (but not limited to) idiopathic thrombocytopenic purpura, disseminated
             intravascular coagulation, or congenital platelet dysfunction

          -  Patients who have GI bleeding that required medical intervention within the previous 6
             weeks (unless definitive surgery has been performed.)

          -  Patients who have a platelet count less than 100,000, as determined within the 28 days
             prior to treatment

          -  Pre-existing or current dependence on opioids.

          -  Subjects who have participated in an investigational drug trial in the 30 days prior
             to the screening visit

          -  Subjects with uncontrolled hypertension