An fMRI Study Of Brain Response In Patients With Fibromyalgia

NCT ID: NCT00760474

Last Updated: 2021-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-03-31

Brief Summary

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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

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Methodology study

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pregabalin, then placebo

Group Type EXPERIMENTAL

Pregabalin, then placebo

Intervention Type 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

Group Type EXPERIMENTAL

Placebo, then pregabalin

Intervention Type 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.

Interventions

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Pregabalin, then placebo

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.

Intervention Type DRUG

Placebo, then pregabalin

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Ann Arbor, Michigan, United States

Site Status

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33982890 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26816332 (View on PubMed)

Related Links

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Other Identifiers

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A0081211

Identifier Type: -

Identifier Source: org_study_id

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