NCT00760474

An fMRI Study Of Brain Response In Patients With Fibromyalgia

A Double-Blind, Placebo-Controlled Cross-Over Study In Fibromyalgia Subjects To Examine Effects Of Pregabalin On Brain Response To Mechanical Pain As Assessed By Functional Magnetic Resonance Imaging, Proton Magnetic Resonance Spectroscopy And Subjective Ratings

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance imaging) is an efficient way to show whether new pain medications are effective in treating fibromyalgia.

Detailed description

Methodology study

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Pregabalin, then placebo	Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
DRUG	Placebo, then pregabalin	Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-09-26
• Last updated: 2021-01-22
• Results posted: 2012-04-04

Locations

2 sites across 1 country: United States