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

NCT01230411 | Completed Phase 4 Results

• 1 other identifier: SDS/IVIb/01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Episodic Migraine

Keywords

Episodic migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  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 severe or moderate decreased to mild or headache-free, respectively.

  2 hours

Study Arms (2)

placebo

PLACEBO COMPARATOR

IV saline administration as placebo

Other: saline placebo

Ibuprofen

EXPERIMENTAL

IV ibuprofen

Drug: Ibuprofen

Interventions

saline placebo OTHER

250 cc of placebo administered IV

placebo

Ibuprofen DRUG

800 mg ibuprofen in 250 cc saline administered IV

Also known as: Caldolor

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Yuan H, Curran JG, Keith SW, Hopkins MM, Silberstein SD. Intravenous ibuprofen for acute treatment of migraine: A double-blind, randomized, placebo-controlled pilot study. Headache. 2021 Oct;61(9):1432-1440. doi: 10.1111/head.14214. Epub 2021 Oct 3.

  PMID: 34601736 DERIVED

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Slow enrollment and small sample size impacted the type 1 error, study power, and quality. The randomization failed to balance the distribution of migraine duration between the two groups. No blinding assessment was done. The primary endpoint of 2HR pain relief for acute migraine treatment was the most common outcome measure at the time.

Results Point of Contact

• Title: Dr. Hsiangkuo Yuan
• Organization: Thomas Jefferson University- Jefferson Headache Center

Hsiangkuo.Yuan@jefferson.edu

2159552243

Study Officials

• Stephen D. Silberstein, M.D.

  Jefferson Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: June 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 6, 2022
• Results First Posted: September 6, 2022

Record last verified: 2022-08

Locations

US (1)