A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

  • STATUS
    Recruiting
  • End date
    Sep 21, 2022
  • participants needed
    30
  • sponsor
    H. Lundbeck A/S
Updated on 26 September 2021
body mass index
sham treatment

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.

Details
Condition Fibromyalgia, Myofascial Pain Syndrome, fibro
Treatment Placebo, Lu AG06466
Clinical Study IdentifierNCT04974359
SponsorH. Lundbeck A/S
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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