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Study terminated due to enrolment challenges.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG06466 | Experimental | Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods. |
|
| Placebo | Placebo Comparator | Participants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 | Drug | Lu AG06466 - capsules |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 22 of each 22-day treatment period |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative NeuroScience Network LLC | Long Beach | California | 90806 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Drug |
Placebo - capsules |
|
| D009422 |
| Nervous System Diseases |