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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This is a 3 visit trial: screening visit, treatment visit, and final visit. Screening visit
      and a treatment visit may occur on the same day. Additionally, there will be one follow-up
      phone call at 24 hours post-dose. Subjects will be screened and the investigator will
      determine whether or not the subject experiences episodic migraine headaches. When a
      potential subject is seen as an office patient at the Jefferson Headache Center, has a
      headache, and is referred by the PI or co-investigator to this study, the referring study
      physician will document that the subject's cognition is intact and the subject is able to
      understand and sign the informed consent at that time. If the potential subject's cognition
      is affected by the migraine, the subject must return to the Jefferson Headache Center for the
      research screening visit when the headache and cognitive difficulties have resolved. Subjects
      who are not being seen as an office patient on the day of screening must be headache-free at
      the time of screening.

      Those subjects who meet the qualifying criteria will be eligible for treatment in the study.
      Subjects who qualify will be asked to come to the Jefferson Headache Center within 2 to 72
      hours following the onset of pain.

      IVIb or placebo will be administered intravenously as the study treatment. For active
      treatment, 800 mg of injectable ibuprofen will be placed in 250 ml of normal saline, and
      infused over 7-10 minutes. (Infusion time may be increased up to 1 hour if necessary due to
      possible anatomical restrictions). The placebo group will receive 250 ml of normal saline,
      infused over 7-10 minutes. (Infusion time may be increased up to 1 hour if necessary due to
      possible anatomical restrictions). Safety and efficacy assessments will be made periodically
      just prior to and after administration of study drug. Migraine pain and associated symptom
      assessments will be measured by the subjects for 24 hours from the administration of study
      drug for the treated attack. If subjects still have a moderate to severe headache at 2 hours
      after receiving double-blind study drug, they will receive a rescue dose of 800 mg. IV
      Ibuprofen. Subjects will be discharged at 4 hours post study drug dose, or when clinically
      indicated.
    

Intervention name(s): saline placebo; Ibuprofen
Intervention type(s): Other; Drug
Intervention description(s): 250 cc of placebo administered IV; 800 mg ibuprofen in 250 cc saline administered IV
Other intervention name(s): Caldolor
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Episodic migraine