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Completed

NCT Number: NCT04147858

Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aptinyx Clinical Site, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NYX-2925

Drug

NYX-2925 administered orally

Placebo

Drug

Placebo administered orally

Primary outcomes

  1. Change in the Mean Numerical Rating Scale (NRS) Score

    Time frame: Week 12

    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)

Secondary outcomes

  1. Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12

    Time frame: Week 12

    Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12

  2. Daily Sleep Interference (DSIS) Score

    Time frame: Week 12

    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.

  3. Number of Subjects Achieving ≥30% Pain Reduction

    Time frame: Week 12

    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).

  4. Number of Subjects Achieving ≥50% Pain Reduction

    Time frame: Week 12

    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)

  5. Fibromyalgia Impact Questionnaire-Revised (FIQR) Score

    Time frame: Week 12

    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

  6. Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score

    Time frame: Week 12

    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.

  7. Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score

    Time frame: Week 12

    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

  8. Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score

    Time frame: Week 12

    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.

  9. Use of Rescue Medication

    Time frame: Week 12

    The number of subjects using rescue medication.

Sponsors and collaborators

Lead sponsor

Aptinyx

Industry

Collaborators

  • Worldwide Clinical Trials

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2019
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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