Clinical trial NCT00760474: An fMRI Study Of Brain Response In Patients With Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fibromyalgia
Keywords: Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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

Eligibility 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.

Primary outcomes:
measure: Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Secondary outcomes:
measure: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Gracely Box Scales for Pain Intensity (GBSint) Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers
timeFrame: Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked
timeFrame: Day 58
measure: Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria
timeFrame: Day 58
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
measure: Pain Catastrophizing Scale (PCS) Including Outliers
timeFrame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Locations:
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ichesco E, Peltier SJ, Mawla I, Harper DE, Pauer L, Harte SE, Clauw DJ, Harris RE. Prediction of Differential Pharmacologic Response in Chronic Pain Using Functional Neuroimaging Biomarkers and a Support Vector Machine Algorithm: An Exploratory Study. Arthritis Rheumatol. 2021 Nov;73(11):2127-2137. doi: 10.1002/art.41781. Epub 2021 Sep 22.
citation: Puiu T, Kairys AE, Pauer L, Schmidt-Wilcke T, Ichesco E, Hampson JP, Napadow V, Clauw DJ, Harris RE. Association of Alterations in Gray Matter Volume With Reduced Evoked-Pain Connectivity Following Short-Term Administration of Pregabalin in Patients With Fibromyalgia. Arthritis Rheumatol. 2016 Jun;68(6):1511-21. doi: 10.1002/art.39600.