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

NCT01230411 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-09-06

Study results available
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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

Interventions

OTHER

saline placebo

250 cc of placebo administered IV

DRUG

Ibuprofen

800 mg ibuprofen in 250 cc saline administered IV

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Stephen D. Silberstein, M.D. · Jefferson Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2017-06-30
Completion
2017-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230411 on ClinicalTrials.gov