An fMRI Study Of Brain Response In Patients With Fibromyalgia
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: Placebo, then pregabalin (Drug); Pregabalin, then placebo (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
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.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled Cross-Over Study In Fibromyalgia Subjects To Examine Effects Of Pregabalin On Brain Reponse To Mechanical Pain As Assessed By Functional Magnetic Resonance Imaging, Proton Magnetic Responance Spectroscopy And Subjective Ratings
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study
Primary outcome: Magnetic resonance imaging will be used to measure brain glutamine and glutamate levels.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.
Secondary outcome: Pain will be evaluated using the Gracely Box Scales several times during each imaging session.The modified Brief Inventory daily pain diary will be used to evaluate clinical pain. The Short-Form McGill Pain Questionnaire will be used to evaluate pain. The Hospital Anxiety and Depression Scale will be used to evaluate anxiety and depression levels. The Pain Catastrophizing Scale will be used to evaluate the extent of catastrophizing.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2008
Ending date: December 2009
Last updated: October 24, 2008
|
