Trial · NCT00760474
An fMRI Study Of Brain Response In Patients With Fibromyalgia
NCT00760474, Phase 1, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-04-04
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ConductScience Library. An fMRI Study Of Brain Response In Patients With Fibromyalgia. Trials, record NCT00760474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00760474
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An fMRI Study Of Brain Response In Patients With Fibromyalgia
- NCT number
- NCT00760474
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 27 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- Pregabalin, then placebo, Placebo, then pregabalin
- First posted
- 2008-09-26
- Last updated
- 2021-01-22
- Results first posted
- 2012-04-04
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | 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. |
| 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 | 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. |
| 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 | 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 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. |
| Secondary | Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. |
| Secondary | Gracely Box Scales for Pain Intensity (GBSint) Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. |
| Secondary | Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers | Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. |
| Secondary | Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | 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. | ratio | MEAN |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC). | percent change | LEAST_SQUARES_MEAN |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS. | percent change in BOLD signal | MEAN |
| SECONDARY | Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | Participants in FAS with quality resting state data (data able to be corrected for motion \[head and cardiorespiratory artifacts\]). | z-score | MEAN |
| SECONDARY | Gracely Box Scales for Pain Intensity (GBSint) Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers | Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Pregabalin | Glu/Cr ratio posterior insula - pre-dose | 1.1751 | Standard Deviation 0.119537 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Placebo | Glu/Cr ratio posterior insula - pre-dose | 1.13253 | Standard Deviation 0.123897 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Pregabalin | Glu/Cr ratio posterior insula - post-dose | 1.1046 | Standard Deviation 0.14180 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Placebo | Glu/Cr ratio posterior insula - post-dose | 1.17129 | Standard Deviation 0.151535 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Pregabalin | Gln/Cr ratio posterior insula - pre-dose | 0.5311 | Standard Deviation 0.117359 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Placebo | Gln/Cr ratio posterior insula - pre-dose | 0.52635 | Standard Deviation 0.143649 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Pregabalin | Gln/Cr ratio posterior insula - post-dose | 0.4857 | Standard Deviation 0.14534 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Placebo | Gln/Cr ratio posterior insula - post-dose | 0.51553 | Standard Deviation 0.147882 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Pregabalin | Glx/Cr ratio posterior insula - pre-dose | 1.70624 | Standard Deviation 0.177312 | ratio |
| Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Placebo | Glx/Cr ratio posterior insula - pre-dose | 1.65894 | Standard Deviation 0.215505 | ratio |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (P1) | STARTED | Pregabalin First, Then Placebo | 13 | |
| Period 1 (P1) | STARTED | Placebo First, Then Pregabalin | 14 | |
| Period 1 (P1) | Treated | Pregabalin First, Then Placebo | 13 | |
| Period 1 (P1) | Treated | Placebo First, Then Pregabalin | 14 | |
| Period 1 (P1) | Overall Number of Unique Participants | Pregabalin First, Then Placebo | 12 | |
| Period 1 (P1) | Overall Number of Unique Participants | Placebo First, Then Pregabalin | 13 | |
| Period 1 (P1) | COMPLETED | Pregabalin First, Then Placebo | 12 | |
| Period 1 (P1) | COMPLETED | Placebo First, Then Pregabalin | 13 | |
| Period 1 (P1) | NOT COMPLETED | Pregabalin First, Then Placebo | 1 | |
| Period 1 (P1) | NOT COMPLETED | Placebo First, Then Pregabalin | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | Pregabalin | 1 | 24 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 0 | 25 | |
| other | Tinnitus | Ear and labyrinth disorders | Pregabalin | 0 | 24 | |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 1 | 25 | |
| other | Vision blurred | Eye disorders | Pregabalin | 1 | 24 | |
| other | Vision blurred | Eye disorders | Placebo | 0 | 25 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin | 1 | 24 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 25 | |
| other | Chest discomfort | General disorders | Pregabalin | 0 | 24 | |
| other | Chest discomfort | General disorders | Placebo | 1 | 25 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 18 | 24 |
| Total, other adverse events | Placebo | 13 | 25 |
| Total, serious adverse events | Pregabalin | 1 | 24 |
| Total, serious adverse events | Placebo | 1 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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