FibromyalgiaPhase 1NCT00760474

An fMRI Study Of Brain Response In Patients With Fibromyalgia

A Phase 1 study of Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Fibromyalgia
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 2 sitesUnited States
Study dates: Jan 2009to Mar 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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

Read the detailed description

Methodology study

Conditions: Fibromyalgia
Being tested: Pregabalin, then placebo, Placebo, then pregabalin
Keywords: Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging
Medical subject headings: Fibromyalgia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pregabalin, then placeboDrug
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.
Placebo, then pregabalinDrug
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.

Study groups in NCT00760474
Study group	Role	What they receive
Pregabalin, then placebo	Experimental	Not described Receives: Drug: Pregabalin, then placebo
Placebo, then pregabalin	Experimental	Not described Receives: Drug: Placebo, then pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)
Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
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
BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)

Secondary outcomes (12)

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
BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined ROI brain regions in response to checkerboard visual stimuli (flashing at 8 hertz [Hz]). Reported as percent change between the pre-dose (baseline) and post-dose values.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions
Resting state brain activity assessed for correlation of brain seed region (pIns, anIns) to ROI connectivity at baseline (pre-dose) and post-dose (pre minus post) measured using z-score (mean of 0, standard deviation [SD] of 1); range approximately -3 to +3. Positive (+) z-scores reflect greater connectivity (+correlation between seed region and ROI). Negative (-) z-scores reflect -connectivity (anti-correlation between seed region and ROI). ROIs include PCC and IPL from within the default mode network (DMN). DMN is a constellation of regions in which connectivity is augmented in fibromyalgia.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Gracely Box Scales for Pain Intensity (GBSint) Including Outliers
Minimum and maximum pain intensity acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (no pain sensation) to 20 (extremely intense). Baseline and Post-dose data for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers
Minimum and maximum pain unpleasantness acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (neutral) to 20 (very intolerable). Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
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
The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 7 day average pain score was defined as the mean daily pain NRS value for the last 7 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
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
The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 3 day average pain score was defined as the mean daily pain NRS value for the last 3 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
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
The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The individual daily pain score was defined as the final score recorded in the last pain diary of the treatment period 24 hours prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers
SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers
SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers
SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by the participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12). Total (overall) score was sum of items 1 to 15, range 0 to 45; higher scores indicated higher pain/impact. Any observation with a studentized residual >3 or <-3 was considered an outlier.
Measured: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked
BP cuff evoked allodynia assessed based on participant response to the following question "When I take your blood pressure, tell me if the cuff's pressure is painful". A standard BP cuff was inflated at approximately 10 millimeters of mercury (mm Hg) per second up to 180 mm Hg or to point when participant experienced pain; performed 3 times on each arm whether or not pain was reported. If no pain elicited at 180 mm Hg, it was recorded that no sphygmomanometry-evoked allodynia occurred. If pain was reported, value (in mm Hg) at which pain first occured was recorded for each of the assessments.
Measured: Day 58
Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria
Participant rated severity of pain upon application of 4 kilograms (kg) pressure via dolorimeter at the bilateral epicondyle tender points (2 tender points, 2 centimeters distal to the epicondyles) described in the American College of Rheumatology (ACR) classification criteria and scored on a 0 (no pain) to 10 (worst possible pain) rating scale. Each arm was to be assessed for any pain (one point on each arm) with the application of pressure.
Measured: Day 58

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Mar 2011

First posted26 Sep 2008 (estimated)
Study startJan 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00760474
Sponsor's protocol ID: A0081211
Status last verified: Nov 2018
First submitted: 25 Sep 2008
Last updated: 22 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 33982890
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.
PubMed 26816332

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00760474
Acronym / sponsor ID: A0081211
Conditions: Fibromyalgia
Keywords: Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 26 Sep 2008 (estimated)
Results: Posted 4 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Methodology study

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pregabalin, then placebo	Experimental	Drug: Pregabalin, then placebo
Placebo, then pregabalin	Experimental	Drug: Placebo, then pregabalin

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pregabalin, then placeboPlacebo 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	Pregabalin, then placebo
Placebo, then pregabalinPlacebo 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

Primary outcome

Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.
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
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier.

12 secondary outcomes

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
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Gracely Box Scales for Pain Intensity (GBSint) Including Outliers
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers
Time frame: Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
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
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
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
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
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
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers
Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked
Time frame: Day 58
Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria
Time frame: Day 58

Results and safety

Results posted to the registry on 4 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin First, Then Placebo	13	12
Placebo First, Then Pregabalin	14	13

Primary outcome: Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)

Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51). Mean (Standard Deviation). Unit: ratio

Measure	Pregabalin n = 17	Placebo n = 17
Glu/Cr ratio posterior insula - pre-dose	1.1751 (0.119537)	1.13253 (0.123897)
Glu/Cr ratio posterior insula - post-dose	1.1046 (0.14180)	1.17129 (0.151535)
Gln/Cr ratio posterior insula - pre-dose	0.5311 (0.117359)	0.52635 (0.143649)
Gln/Cr ratio posterior insula - post-dose	0.4857 (0.14534)	0.51553 (0.147882)
Glx/Cr ratio posterior insula - pre-dose	1.70624 (0.177312)	1.65894 (0.215505)
Glx/Cr ratio posterior insula - post-dose	1.5903 (0.19461)	1.68747 (0.227398)
Glu/Cr ratio anterior insula - pre-dose	1.22731 (0.154333)	1.23788 (0.183282)
Glu/Cr ratio anterior insula - post-dose	1.2393 (0.22290)	1.18524 (0.164847)

Pregabalin: Mean Difference (Final Values): -0.070, p = 0.083, t-test, 2 sided
Placebo: p = 0.436, t-test, 2 sided
Pregabalin: p = 0.306, t-test, 2 sided

Population analysed: Full Analysis Set (FAS) all participants who received a minimum fixed dose of 300 mg/day of study treatment. N=number of participants with analyzable data at observation.

Primary outcome: 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

Time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51). Least squares mean (Standard Error). Unit: percent change

Measure	Pregabalin n = 16	Placebo n = 16
Anterior Cingulate	0.008 (0.0454)	-0.024 (0.0454)
Brodman Area (BA) 22	-0.050 (0.0709)	0.029 (0.0709)
BA40	-0.047 (0.0436)	0.026 (0.0436)
Left (L)_Anterior Insula (anIns)	0.073 (0.0378)	0.044 (0.0378)
L_Amygdala	-0.040 (0.0502)	0.041 (0.0502)
L_Cerebellum	-0.056 (0.0317)	0.021 (0.0317)
L_DLPFC	-0.002 (0.0255)	0.023 (0.0255)
L_Mid Insula	-0.011 (0.0672)	0.100 (0.0672)

Pregabalin vs Placebo: Least Squares (LS) Mean difference: 0.032 (95% CI -0.1081 to 0.1714), p = 0.6347, Mixed Models Analysis
Pregabalin vs Placebo: Least Squares (LS) Mean difference: -0.079 (95% CI -0.3356 to 0.1771), p = 0.5181, Mixed Models Analysis
Pregabalin vs Placebo: Least Squares (LS) Mean difference: -0.072 (95% CI -0.2161 to 0.0714), p = 0.2987, Mixed Models Analysis

Population analysed: FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC).

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (all causalities) were reported from the time of first dose of study treatment up to 28 days after last dose of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	1 of 24 (4.2%)	18 of 24 (75%)	Not reported
Placebo	1 of 25 (4%)	13 of 25 (52%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33982890Ichesco 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.
Derived from this study: PubMed 26816332Puiu 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) (time frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00760474, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.