Phase 3 Fibromyalgia Trial, Recruiting NCT07398417 Sponsor: Axsome Therapeutics, Inc. Condition: Fibromyalgia
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Phase 3 Fibromyalgia Trial, Recruiting

NCT07398417
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with fibromyalgia based on specific medical guidelines (the 2016 ACR diagnostic criteria — confirm with trial site if unsure which criteria your diagnosis was based on)
  • You are male or female, aged 18 or older
  • You are willing and able to sign a consent form agreeing to take part before any study activities begin

Who may not be able to join:

  • You have previously taken part in a clinical trial involving a medication called reboxetine or esreboxetine, or you are currently taking reboxetine for any reason
  • You are unable to follow or keep up with the study procedures and requirements
  • A doctor involved in the trial has decided, for medical reasons, that it would not be appropriate for you to take part (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 212-332-5061

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Axsome Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
14 January 2026
Est. completion
1 March 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Time from randomization to loss of therapeutic response

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov