The purpose of this study is to find out the effect of Lu AG06466 on the body in participants with fibromyalgia by assessing pain levels, brain signal changes, and psychiatric (mental) assessments.
This study will include 2 treatment periods and will utilize a crossover study design with a 7- to 14-day washout period between each 22-day treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Lu AG06466 - capsules
Placebo - capsules
Collaborative NeuroScience Network LLC
Long Beach, California, United States
Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test
BOLD response was evaluated using Functional Magnetic Resonance Imaging (fMRI). During the evoked-pain test, each participant will undergo a block design scan, during which 3 cuff pressures ('light touch' = 30 millimeter of mercury \[mmHg\]; 'equal pressure' = 120 mmHg; 'equal pain' = 40 to 60/100 Numeric Rating Scale \[NRS\] units) will be applied to the left calf using the pressure cuff device in pseudo random order.
Time frame: Day 22 of each 22-day treatment period
Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels
Each participant will undergo a task-free resting state scan, where in they will be instructed to focus on a static fixation cross.
Time frame: Day 22 of each 22-day treatment period
fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation
Each participant will undergo a block design scan, with alternating blocks of flashing checkerboard and a static fixation cross.
Time frame: Day 22 of each 22-day treatment period
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