Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Placebo; Drug: NYX-2925

Detailed Description

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia.

This 13- to 16-week study will include a 1- to 4-week Screening Period followed by a 12-week double-blind, randomized, placebo-controlled Treatment Period.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Aptinyx Clinical Site
  • California
    • Culver City, California, United States, 90230
      • Aptinyx Clinical Site
    • Fresno, California, United States, 93710
      • Aptinyx Clinical Site
    • Orange, California, United States, 92868
      • Aptinyx Clinical Site
    • Redlands, California, United States, 92374
      • Aptinyx Clinical Site
    • Temecula, California, United States, 92591
      • Aptinyx Clinical Site
    • Torrance, California, United States, 90502
      • Aptinyx Clinical Site
  • Florida
    • Fernandina Beach, Florida, United States, 32034
      • Aptinyx Clinical Site
    • Jacksonville, Florida, United States, 32256
      • Aptinyx Clinical Site
    • Jacksonville, Florida, United States, 32224
      • Aptinyx Clinical Site
    • Lady Lake, Florida, United States, 32159
      • Aptinyx Clinical Site
    • Miami, Florida, United States, 33165
      • Aptinyx Clinical Site
    • Orlando, Florida, United States, 32801
      • Aptinyx Clinical Site
    • Palmetto Bay, Florida, United States, 33157
      • Aptinyx Clinical Site
    • Winter Park, Florida, United States, 32789
      • Aptinyx Clinical Site
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Aptinyx Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Aptinyx Clinical Site
    • Flossmoor, Illinois, United States, 60422
      • Aptinyx Clinical Site
    • Gurnee, Illinois, United States, 60031
      • Aptinyx Clinical Site
    • Skokie, Illinois, United States, 60076
      • Aptinyx Clinical Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Aptinyx Clinical Site
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Aptinyx Clinical Site
  • Kansas
    • Newton, Kansas, United States, 67114
      • Aptinyx Clinical Site
    • Prairie Village, Kansas, United States, 66208
      • Aptinyx Clinical Site
    • Wichita, Kansas, United States, 67205
      • Aptinyx Clinical Site
  • Massachusetts
    • Roslindale, Massachusetts, United States, 02131
      • Aptinyx Clinical Site
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Aptinyx Clinical Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Aptinyx Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Aptinyx Clinical Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Aptinyx Clinical Site
    • New York, New York, United States, 10036
      • Aptinyx Clinical Site
    • New York, New York, United States, 10017
      • Aptinyx Clinical Site
    • Staten Island, New York, United States, 10312
      • Aptinyx Clinical Site
    • Williamsville, New York, United States, 14221
      • Aptinyx Clinical Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Aptinyx Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • Aptinyx Clinical Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Aptinyx Clinical Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Aptinyx Clinical Site
  • Texas
    • Austin, Texas, United States, 78737
      • Aptinyx Clinical Site
    • Houston, Texas, United States, 77077
      • Aptinyx Clinical Site
  • Virginia
    • Danville, Virginia, United States, 24541
      • Aptinyx Clinical Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Aptinyx Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Informed consent
• Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening and reports at least moderate pain over the last week
• Stable protocol allowed medication and other therapies during the study
• Agrees to use highly effective birth control during the study
• Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

• Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
• Current or historical serious medical conditions
• Prior participation in NYX-2925 clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered orally.	Drug: Placebo; Placebo administered orally
Experimental: NYX-2925 50 mg; NYX-2925 50 mg administered orally.	Drug: NYX-2925; NYX-2925 administered orally
Experimental: NYX-2925 100 mg; NYX-2925 100 mg administered orally.	Drug: NYX-2925; NYX-2925 administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Mean Numerical Rating Scale (NRS) Score	Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12	Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12	Week 12
Daily Sleep Interference (DSIS) Score	Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep.	Week 12
Number of Subjects Achieving ≥30% Pain Reduction	Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain).	Week 12
Number of Subjects Achieving ≥50% Pain Reduction	Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)	Week 12
Fibromyalgia Impact Questionnaire-Revised (FIQR) Score	Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia	Week 12
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score	Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance.	Week 12
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score	Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue	Week 12
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score	Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function.	Week 12
Use of Rescue Medication	The number of subjects using rescue medication.	Week 12

Collaborators and Investigators

• Sponsor: Aptinyx
• Collaborators: Worldwide Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: NYX-2925-2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No