Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
ConditionFibromyalgia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAxsome Therapeutics, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
AXS-14 (Esreboxetine)
DrugAXS-14 tablets taken once daily
Placebo
DrugPlacebo tablets taken once daily
Treatment groups
620 Participants
are divided into 2 treatment groupsGroup A: AXS-14 (esreboxetine)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time from randomization to loss of therapeutic response
Time frame
12 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov