An fMRI Study Of Brain Response In Patients With Fibromyalgia

NCT00760474 | Completed Phase 1 Results

• 1 other identifier: A0081211
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)

• Gracely Box Scales for Pain Intensity (GBSint) Including Outliers

  Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)

• 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)

• 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)

Other Outcomes (3)

• Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers

  Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)

• Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers

  Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)

• Pain Catastrophizing Scale (PCS) Including Outliers

  Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)

Study Arms (2)

Pregabalin, then placebo

EXPERIMENTAL

Drug: Pregabalin, then placebo

Placebo, then pregabalin

EXPERIMENTAL

Drug: Placebo, then pregabalin

Interventions

Pregabalin, then placebo DRUG

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.

Pregabalin, then placebo

Placebo, then pregabalin DRUG

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 pregabalin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (2)

Pfizer Investigational Site

Ann Arbor, Michigan, 48106, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• 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.

  PMID: 33982890 DERIVED

• 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.

  PMID: 26816332 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: January 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 22, 2021
• Results First Posted: April 4, 2012

Record last verified: 2018-11

Locations

US (2)