Phase 3: testing AXS-14 (Esreboxetine) for Fibromyalgia
The study is a Phase 3, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, randomly assigned withdrawal study to assess the how well it works and safety of AXS-14 in the management of fibromyalgia.
Official registry: https://clinicaltrials.gov/study/NCT07398417 · Axsome Therapeutics, Inc. · enrollment listed as 620
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are AXS-14 (Esreboxetine), or Placebo. The registry lists allocation as randomized. The study is a Phase 3, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, randomly assigned withdrawal study to assess the how well it works and safety of AXS-14 in the management of fibromyalgia.
They plan to enroll about 620 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
Interventions: AXS-14 (Esreboxetine), Placebo
Primary outcome (registry wording): Time from randomization to loss of therapeutic response
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria
- Male or female, ≥18 years of age
Who the registry excludes
- 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
Public study contact (from the registry)
Study Director
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
53 listed- Clinical Research Site — Glendale, Arizona (recruiting)
- Clinical Research Site — Phoenix, Arizona (recruiting)
- Clinical Research Site — Tucson, Arizona (recruiting)
- Clinical Research Site — Little Rock, Arkansas (recruiting)
- Clinical Research Site — Anaheim, California (recruiting)
- Clinical Research Site — Oceanside, California (recruiting)
- Clinical Research Site — Redlands, California (recruiting)
- Clinical Research Site — Sacramento, California (recruiting)
- Clinical Research Site — Santa Ana, California (recruiting)
- Clinical Research Site — Cromwell, Connecticut (recruiting)
- Clinical Research Site — Hollywood, Florida (recruiting)
- Clinical Research Site — Jacksonville, Florida (recruiting)
FAQ about this NCT record
Is NCT07398417 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07398417?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07398417?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary