NCT03249103

Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

A Phase 2, Single-Blind, Exploratory, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Daily Oral NYX-2925 in Subjects With Fibromyalgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Aptinyx · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine whether daily dosing with NYX-2925 changes markers of central pain processing in subjects with fibromyalgia by evaluating changes in evoked pain, and visual stimulation, functional magnetic resonance imaging (fMRI), resting state function connectivity magnetic resonance imaging (rs-fcMRI) and proton magnetic resonance spectroscopy (H-MRS) in fibromyalgia subjects on active drug versus placebo.

Detailed description

This is a single-blind, exploratory, placebo-controlled, pilot study to assess the efficacy and safety of daily oral NYX-2925 in fibromyalgia subjects. The study will include a screening period (up to 30 days), a placebo period, an active treatment period with, and a follow-up period as follows: * Placebo PO Every Day (QD) for 2 weeks * NYX-2925 PO QD for 2 weeks (2x) * Follow-up for 1 week Eligible subjects will receive MRIs during the screening period, during the placebo period, during the NYX-2925 PO QD period. Safety assessments will be conducted and adverse events will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected for exploratory analysis. During the follow-up period, an optional MRI will be completed for consenting subjects in order to evaluate duration of effect.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	NYX-2925	NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
DRUG	Placebo oral capsule	Matching placebo capsules.

Timeline

• Start date: 2017-08-14
• Primary completion: 2019-04-18
• Completion: 2019-04-18
• First posted: 2017-08-15
• Last updated: 2022-09-16
• Results posted: 2022-09-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study