A Phase 3 interventional study of AXS-14 (Esreboxetine) and Placebo in Fibromyalgia, sponsored by Axsome Therapeutics, Inc.. Recruiting at 57 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 620 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Up to 12 weeks in the open-label period; * Up to 12 weeks in the randomized double-blind period (if applicable)
Drug: AXS-14 (Esreboxetine)
• Up to 12 weeks in the randomized double-blind period (if applicable)
Drug: Placebo
AXS-14 tablets taken once daily
Placebo tablets taken once daily
Time from randomization to loss of therapeutic response
Time frame: 12 Weeks
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Esreboxetine