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Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NYX-2925
Placebo
Sponsored by
Aptinyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NYX-2925 50 mg

NYX-2925 100 mg

Placebo

Arm Description

NYX-2925 50 mg administered orally.

NYX-2925 100 mg administered orally.

Placebo administered orally.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.
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).
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)
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
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.
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
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.
Use of Rescue Medication
The number of subjects using rescue medication.

Full Information

First Posted
October 29, 2019
Last Updated
April 7, 2023
Sponsor
Aptinyx
Collaborators
Worldwide Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT04147858
Brief Title
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptinyx
Collaborators
Worldwide Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NYX-2925 50 mg
Arm Type
Experimental
Arm Description
NYX-2925 50 mg administered orally.
Arm Title
NYX-2925 100 mg
Arm Type
Experimental
Arm Description
NYX-2925 100 mg administered orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally.
Intervention Type
Drug
Intervention Name(s)
NYX-2925
Intervention Description
NYX-2925 administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally
Primary Outcome Measure Information:
Title
Change in the Mean Numerical Rating Scale (NRS) Score
Description
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)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12
Description
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
Title
Daily Sleep Interference (DSIS) Score
Description
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.
Time Frame
Week 12
Title
Number of Subjects Achieving ≥30% Pain Reduction
Description
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).
Time Frame
Week 12
Title
Number of Subjects Achieving ≥50% Pain Reduction
Description
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)
Time Frame
Week 12
Title
Fibromyalgia Impact Questionnaire-Revised (FIQR) Score
Description
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
Time Frame
Week 12
Title
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score
Description
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.
Time Frame
Week 12
Title
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score
Description
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
Time Frame
Week 12
Title
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score
Description
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.
Time Frame
Week 12
Title
Use of Rescue Medication
Description
The number of subjects using rescue medication.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aptinyx Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Aptinyx Clinical Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Aptinyx Clinical Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Aptinyx Clinical Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Aptinyx Clinical Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Aptinyx Clinical Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Aptinyx Clinical Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Aptinyx Clinical Site
City
Fernandina Beach
State/Province
Florida
ZIP/Postal Code
32034
Country
United States
Facility Name
Aptinyx Clinical Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Aptinyx Clinical Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Aptinyx Clinical Site
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Aptinyx Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Aptinyx Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Aptinyx Clinical Site
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Aptinyx Clinical Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Aptinyx Clinical Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Aptinyx Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Aptinyx Clinical Site
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Aptinyx Clinical Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Aptinyx Clinical Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Aptinyx Clinical Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Aptinyx Clinical Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Aptinyx Clinical Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Aptinyx Clinical Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Aptinyx Clinical Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Aptinyx Clinical Site
City
Roslindale
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Aptinyx Clinical Site
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Aptinyx Clinical Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Aptinyx Clinical Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Aptinyx Clinical Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Aptinyx Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Aptinyx Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Aptinyx Clinical Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Aptinyx Clinical Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Aptinyx Clinical Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Aptinyx Clinical Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Aptinyx Clinical Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Aptinyx Clinical Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Aptinyx Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Aptinyx Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77077
Country
United States
Facility Name
Aptinyx Clinical Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Aptinyx Clinical Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

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