Phase 1 N=27 Randomized Quadruple-blind Other

An fMRI Study Of Brain Response In Patients With Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT00760474 ↗

Enrolled (actual)

Serious AEs

4.1%

Results posted

Apr 2012

Primary outcome: Primary: Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) — 1.1751; 1.13253; 1.1046; 1.17129 ratio — p=0.083

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Pregabalin, then placebo (Drug); Placebo, then pregabalin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)	1.1751; 1.13253; 1.1046; 1.17129; 0.5311; 0.52635	0.083
PRIMARY 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	0.008; -0.024; -0.050; 0.029; -0.047; 0.026	0.6347
SECONDARY 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	0.32; -0.05; 0.23; 0.00; 0.27; 0.05	—
SECONDARY Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions	1.1647; 1.5405; 2.1504; 1.2409; 3.1486; 1.3267	—
SECONDARY Gracely Box Scales for Pain Intensity (GBSint) Including Outliers	4.1184; 3.4725; 14.5701; 15.6117	—
SECONDARY Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers	3.3924; 3.4258; 10.1576; 11.2742	—
SECONDARY 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	4.1014; 4.7038	—
SECONDARY 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	4.3467; 4.7745	—
SECONDARY 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	4.3110; 5.0527	—
SECONDARY Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers	1.4100; 1.8173	—
SECONDARY Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers	8.6641; 9.4722	—
SECONDARY Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers	10.0862; 11.2774	—
SECONDARY Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked	107.92; 129.31	—
SECONDARY Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria	6.25; 5.72	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00760474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.