A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT04974359|
Recruitment Status : Terminated (Study terminated due to enrolment challenges.)
First Posted : July 23, 2021
Last Update Posted : February 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Lu AG06466 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Lu AG06466 Phase IB Study in Patients With Fibromyalgia Using Neuroimaging to Investigate Its Pharmacodynamic Effects on Central Pain Processing and Neuroinflammation|
|Actual Study Start Date :||June 24, 2021|
|Actual Primary Completion Date :||January 26, 2022|
|Actual Study Completion Date :||January 26, 2022|
Experimental: Lu AG06466
Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.
Drug: Lu AG06466
Lu AG06466 - capsules
Placebo Comparator: Placebo
Participants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.
Placebo - capsules
- Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test [ Time Frame: Day 22 of each 22-day treatment period ]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.
- Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels [ Time Frame: Day 22 of each 22-day treatment period ]Each participant will undergo a task-free resting state scan, where in they will be instructed to focus on a static fixation cross.
- fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation [ Time Frame: Day 22 of each 22-day treatment period ]Each participant will undergo a block design scan, with alternating blocks of flashing checkerboard and a static fixation cross.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974359
|United States, California|
|Collaborative NeuroScience Network LLC|
|Long Beach, California, United States, 90806|
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@Lundbeck.com|