Clinical Trial Finder

A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender Female
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04974359
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 H. Lundbeck A/S
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Email contact via H. Lundbeck A/S
Principal Investigator Affiliation [email protected]
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Fibromyalgia
Additional Details

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.

Arms & Interventions

Arms

Experimental: Lu AG06466

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

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.

Interventions

Drug: - Lu AG06466

Lu AG06466 - capsules

Drug: - Placebo

Placebo - capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Collaborative NeuroScience Network LLC, Long Beach, California

Status

Recruiting

Address

Collaborative NeuroScience Network LLC

Long Beach, California, 90806

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