DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Thomas Jefferson University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Episodic Migraine

Intervention: saline placebo (Other); Ibuprofen (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Thomas Jefferson University

Official(s) and/or principal investigator(s):
Stephen D. Silberstein, M.D., Principal Investigator, Affiliation: Jefferson Headache Center

Overall contact:
Meryl Latsko, MD,MPH, Phone: 215-955-9477, Email: meryl.latsko@jefferson.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Meryl Latsko, MD,MPH, Phone: 215-955-9477, Email: meryl.latsko@jefferson.edu

Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States; Recruiting
Kathleen Bradley, BSN, Email: kathleen.bradley@jefferson.edu
Additional Information

Starting date: June 2011
Last updated: March 17, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017