NCT07398417 · Axsome Therapeutics, Inc.
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
(FORWARD)
What this study is about
The study is a Phase 3, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, randomly assigned withdrawal study to assess the effectiveness and safety of AXS-14 in the management of fibromyalgia.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Little Rock, Arkansas
- Santa Ana, California
- Cromwell, Connecticut
- Jacksonville, Florida
- Orlando, Florida
- Tampa, Florida
- Atlanta, Georgia
- Overland Park, Kansas
- Louisville, Kentucky
- Prairieville, Louisiana
- Springfield, Missouri
- Town and Country, Missouri
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 9, 2026 · Source of record for eligibility and locations