RecruitingNCT07398417ClinicalTrials.gov record

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Fibromyalgia

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 620 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Double masked

AXS-14 (esreboxetine)

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)

Placebo

• Up to 12 weeks in the randomized double-blind period (if applicable)

Drug: Placebo

AXS-14 (Esreboxetine) DRUG

AXS-14 tablets taken once daily

Placebo DRUG

Placebo tablets taken once daily

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Time from randomization to loss of therapeutic response

Time frame: 12 Weeks

Not reported in this registry record.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (57)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

57 locations

Clinical Research SiteGlendale, Arizona, United StatesRecruiting