NCT04974359

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2022

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

June 28, 2021

Last Update Submit

January 28, 2022

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Lu AG06466

EXPERIMENTAL

Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.

Drug: Lu AG06466

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.

Drug: Placebo

Interventions

Lu AG06466DRUG

Lu AG06466 - capsules

Lu AG06466
PlaceboDRUG

Placebo - capsules

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Collaborative NeuroScience Network LLC

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 23, 2021

Study Start

June 24, 2021

Primary Completion

January 26, 2022

Study Completion

January 26, 2022

Last Updated

February 11, 2022

Record last verified: 2022-01

Locations

US(1)