Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

SDS/IVIb/01


NCT ID:

NCT01230411


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Thomas Jefferson University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Stephen D. Silberstein, M.D.
Principal Investigator
Jefferson Headache Center
Primary Contact:Meryl Latsko, MD,MPH
215-955-9477
meryl.latsko@jefferson.edu
Backup Contact:Kathleen Bradley, BSN, CCRP
215-955-2025
kathleen.bradlely@jefferson.edu

Study Dates

Start Date:June 2011
Completion Date:December 2017
Completion Type:Anticipated
Primary Completion Date:June 2017
Primary Completion Type:Anticipated
Verification Date:June 2016
Last Changed Date:June 13, 2016
First Received Date:October 27, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Time Frame:24 hours
Safety Issues:False
Description:Comparison of proportion of subjects in each treatment group (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 seve

Study Interventions

Intervention Type:Other
Name:saline placebo
Description:250 cc of placebo administered IV
Arm Name:placebo
Intervention Type:Drug
Name:Ibuprofen
Description:800 mg ibuprofen in 250 cc saline administered IV
Arm Name:Ibuprofen
Other Name:Caldolor

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:placebo
Description:IV saline administration as placebo
Study Arm Type:Experimental
Arm Name:Ibuprofen
Description:IV ibuprofen

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Thomas Jefferson University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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