Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 1:02 PM
Study NCT ID:
NCT04974359
Status:
TERMINATED
Last Update Posted:
2022-02-11
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia
Sponsor:
H. Lundbeck A/S
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to enrolment challenges.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: