An fMRI Study Of Brain Response In Patients With Fibromyalgia

Viatris

Status and phase: Completed; Phase 1

Conditions: Fibromyalgia

Treatments: Drug: Pregabalin, then placebo; Drug: Placebo, then pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00760474

A0081211

Details and patient eligibility

About

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.

Full description

Methodology study

Enrollment: 27 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups

Pregabalin, then placebo

Experimental group

Treatment:

Drug: Pregabalin, then placebo

Placebo, then pregabalin

Experimental group

Treatment:

Drug: Placebo, then pregabalin