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New treatment option for Fibromyalgia
Official title Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
ClinicalTrials.gov ID: NCT07398417
What this study is testing
What is AXS-14 (Esreboxetine)?
AXS-14 (Esreboxetine) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for fibromyalgia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
- Male or female, ≥18 years of age.
- Provides written informed consent to participate in the study before conducting any study procedures.
You likely can't join if
- Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Santa Ana, California, United States
- Cromwell, Connecticut, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Overland Park, Kansas, United States
- Louisville, Kentucky, United States
- Prairieville, Louisiana, United States
- Springfield, Missouri, United States
- Town and Country, Missouri, United States
- Tulsa, Oklahoma, United States
- Charleston, South Carolina, United States
- Memphis, Tennessee, United States
- Prosper, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Santa Ana, California, United States; Cromwell, Connecticut, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.