NCT01230411

Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack

A Double-blind, Placebo-controlled Pilot Study to Collect and Evaluate Data on the Use of Intravenous Ibuprofen in the Treatment of an Acute Migraine Attack

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
OTHER	saline placebo	250 cc of placebo administered IV
DRUG	Ibuprofen	800 mg ibuprofen in 250 cc saline administered IV

Timeline

• Start date: 2011-06-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2010-10-29
• Last updated: 2022-09-06
• Results posted: 2022-09-06

Locations

1 site across 1 country: United States