NCT07398417 Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
| NCT ID | NCT07398417 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 620 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 620 participants in total. It began in 2026-01-14 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07398417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07398417 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 620 participants.
Is NCT07398417 currently recruiting?
Yes, NCT07398417 is actively recruiting participants. Contact the research team at AXS-14-FM-301@axsome.com for enrollment information.
Where is the NCT07398417 trial being conducted?
This trial is being conducted at Little Rock, United States, Santa Ana, United States, Cromwell, United States, Jacksonville, United States and 11 additional locations.
Who is sponsoring the NCT07398417 clinical trial?
NCT07398417 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 620 participants.
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