Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Conditions

• Fibromyalgia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AXS-14 (Esreboxetine) — DRUG
  AXS-14 tablets taken once daily
• Placebo — DRUG
  Placebo tablets taken once daily

Study Details

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.

Key Dates

First listed

Feb 9, 2026

Start date

Jan 14, 2026

Status verified

Jul 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

620 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AXS-14 (esreboxetine)
  * Up to 12 weeks in the open-label period; * Up to 12 weeks in the randomized double-blind period (if applicable)
• Placebo Comparator: Placebo
  • Up to 12 weeks in the randomized double-blind period (if applicable)

Primary Outcome Measure

Time from randomization to loss of therapeutic response [ Time Frame: 12 Weeks ]

Central Contacts

• Study Director
  212-332-5061
  [email protected]

Locations (51)

Find similar trials in Glendale, AZ

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