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

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

Sponsors

Lead Sponsor: Thomas Jefferson University

Source Thomas Jefferson University
Brief 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 pilot trial to collect and evaluate 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.

Overall Status Unknown status
Start Date June 2011
Completion Date December 2017
Primary Completion Date June 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Comparison of proportion of subjects in control and active treatment groups who have pain relief at 2 hours after the completion of the double-blind treatment infusion. 24 hours
Enrollment 120
Condition
Intervention

Intervention Type: Other

Intervention Name: saline placebo

Description: 250 cc of placebo administered IV

Arm Group Label: placebo

Intervention Type: Drug

Intervention Name: Ibuprofen

Description: 800 mg ibuprofen in 250 cc saline administered IV

Arm Group Label: Ibuprofen

Other Name: Caldolor

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stephen D. Silberstein, M.D. Principal Investigator Jefferson Headache Center
Overall Contact

Last Name: Meryl Latsko, MD,MPH

Phone: 215-955-9477

Email: [email protected]

Location
Facility: Status: Contact: Jefferson Headache Center Kathleen Bradley, BSN [email protected]
Location Countries

United States

Verification Date

June 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: placebo

Type: Placebo Comparator

Description: IV saline administration as placebo

Label: Ibuprofen

Type: Experimental

Description: IV ibuprofen

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov