A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04974359
• Other study ID #: 19365A
• Status: Terminated
• Phase: Phase 1
• Start date: June 24, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: January 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The participant has a body mass index (BMI) of =18.5 and =38.0 kilograms (kg)/square meter (m^2).
• The participant has a fibromyalgia diagnosis, with self-reported pain visual analogue scale (VAS) score >4, based on a self-reported pain diary assessed for a minimum of 4 out of 7 days prior to the Baseline Visit.
• The participant is, in the opinion of the investigator, eligible based on medical history, a physical examination, a neurological examination, vital signs (including orthostatic vital signs), an electrocardiogram (ECG), and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

• The participant has a disease, including clinically significant liver disease of any origin, or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
• The participant has any other disorder for which the treatment takes priority over the treatment of fibromyalgia in this study or is likely to interfere with the study treatment or impair treatment compliance. Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Lu AG06466
Lu AG06466 - capsules
• Placebo
Placebo - capsules

Locations

Country	Name	City	State
United States	Collaborative NeuroScience Network LLC	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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