A Phase 3 interventional study of AXS-14 (esreboxetine) in Fibromyalgia, sponsored by Axsome Therapeutics, Inc.. Enrolling by invitation at 38 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.
Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 for up to 52 weeks.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 300 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.
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Exclusion Criteria:
Up to 52 weeks.
Drug: AXS-14 (esreboxetine)
AXS-14 tablets taken twice daily.
Long-term Safety
Incidence of treatment-emergent adverse events following dosing with AXS-14
Time frame: Up to 52 weeks.
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for May 2028, 25 months after the start.
Of 17 phase 3 interventional studies under Fibromyalgia, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 26. This study's planned 25 months is above that.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Esreboxetine