An fMRI Study Of Brain Response In Patients With Fibromyalgia - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00760474

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia	Drug: Pregabalin, then placebo Drug: Placebo, then pregabalin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Fibromyalgia MRI Scans

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Magnetic resonance imaging will be used to measure brain glutamine and glutamate levels. [ Time Frame: 4 times on study (last time at Day 51) ] [ Designated as safety issue: No ]
fMRI brain activation signals will be evaluated across the whole brain and in defined brain regions in response to blunt pressure pain and to control visual stimuli. [ Time Frame: 4 times on study (last time at Day 51) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain will be evaluated using the Gracely Box Scales several times during each imaging session. [ Time Frame: 5 times on study (last time on Day 51) ] [ Designated as safety issue: No ]
The modified Brief Inventory daily pain diary will be used to evaluate clinical pain. [ Time Frame: Daily, Days 1-51 ] [ Designated as safety issue: No ]
The Short-Form McGill Pain Questionnaire will be used to evaluate pain. [ Time Frame: 4 times on study (last time Day 51) ] [ Designated as safety issue: No ]
The Hospital Anxiety and Depression Scale will be used to evaluate anxiety and depression levels. [ Time Frame: 4 times on study (last time Day 51) ] [ Designated as safety issue: No ]
The Pain Catastrophizing Scale will be used to evaluate the extent of catastrophizing. [ Time Frame: 4 times on study (last time Day 51) ] [ Designated as safety issue: No ]
Any pain in response to inflation of a blood pressure cuff will be assessed. [ Time Frame: Once at end of study ] [ Designated as safety issue: No ]
Each arm will be assessed for any pain (one point on each arm) with the application of pressure. [ Time Frame: Once at the end of study ] [ Designated as safety issue: No ]

Enrollment:	33
Study Start Date:	January 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pregabalin, then placebo	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.
Experimental: Placebo, then pregabalin	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.

Detailed Description:

Methodology study

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women must have pain due to fibromyalgia
Fibromyalgia must have been diagnosed at least 6 months prior to be eligible for this study

Exclusion Criteria:

Patients with severe depression or other serious illness, who are left-handed, or who are pregnant or nursing are not eligible for this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760474

Locations

United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48106
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00760474 History of Changes
Other Study ID Numbers:	A0081211
Study First Received:	September 25, 2008
Last Updated:	May 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012