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
1 other identifier
interventional
310
1 country
42
Brief Summary
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedStudy Start
First participant enrolled
November 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2022
CompletedResults Posted
Study results publicly available
April 28, 2023
CompletedApril 28, 2023
April 1, 2023
2.6 years
October 29, 2019
March 2, 2023
April 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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
Week 12
Number of Subjects Achieving ≥30% Pain Reduction
Week 12
Number of Subjects Achieving ≥50% Pain Reduction
Week 12
Fibromyalgia Impact Questionnaire-Revised (FIQR) Score
Week 12
- +4 more secondary outcomes
Study Arms (3)
NYX-2925 50 mg
EXPERIMENTALNYX-2925 50 mg administered orally.
NYX-2925 100 mg
EXPERIMENTALNYX-2925 100 mg administered orally.
Placebo
PLACEBO COMPARATORPlacebo administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aptinyxlead
- Worldwide Clinical Trialscollaborator
Study Sites (42)
Aptinyx Clinical Site
Phoenix, Arizona, 85012, United States
Aptinyx Clinical Site
Culver City, California, 90230, United States
Aptinyx Clinical Site
Fresno, California, 93710, United States
Aptinyx Clinical Site
Orange, California, 92868, United States
Aptinyx Clinical Site
Redlands, California, 92374, United States
Aptinyx Clinical Site
Temecula, California, 92591, United States
Aptinyx Clinical Site
Torrance, California, 90502, United States
Aptinyx Clinical Site
Fernandina Beach, Florida, 32034, United States
Aptinyx Clinical Site
Jacksonville, Florida, 32224, United States
Aptinyx Clinical Site
Jacksonville, Florida, 32256, United States
Aptinyx Clinical Site
Lady Lake, Florida, 32159, United States
Aptinyx Clinical Site
Miami, Florida, 33165, United States
Aptinyx Clinical Site
Orlando, Florida, 32801, United States
Aptinyx Clinical Site
Palmetto Bay, Florida, 33157, United States
Aptinyx Clinical Site
Winter Park, Florida, 32789, United States
Aptinyx Clinical Site
Alpharetta, Georgia, 30022, United States
Aptinyx Clinical Site
Chicago, Illinois, 60607, United States
Aptinyx Clinical Site
Flossmoor, Illinois, 60422, United States
Aptinyx Clinical Site
Gurnee, Illinois, 60031, United States
Aptinyx Clinical Site
Skokie, Illinois, 60076, United States
Aptinyx Clinical Site
Evansville, Indiana, 47714, United States
Aptinyx Clinical Site
West Des Moines, Iowa, 50265, United States
Aptinyx Clinical Site
Newton, Kansas, 67114, United States
Aptinyx Clinical Site
Prairie Village, Kansas, 66208, United States
Aptinyx Clinical Site
Wichita, Kansas, 67205, United States
Aptinyx Clinical Site
Roslindale, Massachusetts, 02131, United States
Aptinyx Clinical Site
Hazelwood, Missouri, 63042, United States
Aptinyx Clinical Site
Omaha, Nebraska, 68114, United States
Aptinyx Clinical Site
Las Vegas, Nevada, 89102, United States
Aptinyx Clinical Site
Brooklyn, New York, 11235, United States
Aptinyx Clinical Site
New York, New York, 10017, United States
Aptinyx Clinical Site
New York, New York, 10036, United States
Aptinyx Clinical Site
Staten Island, New York, 10312, United States
Aptinyx Clinical Site
Williamsville, New York, 14221, United States
Aptinyx Clinical Site
Cincinnati, Ohio, 45219, United States
Aptinyx Clinical Site
Oklahoma City, Oklahoma, 73106, United States
Aptinyx Clinical Site
Duncansville, Pennsylvania, 16635, United States
Aptinyx Clinical Site
Memphis, Tennessee, 38119, United States
Aptinyx Clinical Site
Austin, Texas, 78737, United States
Aptinyx Clinical Site
Houston, Texas, 77077, United States
Aptinyx Clinical Site
Danville, Virginia, 24541, United States
Aptinyx Clinical Site
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aptinyx Clinical Development
- Organization
- Aptinyx
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization algorithm, randomization allocation, allocation to study drug or placebo.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 1, 2019
Study Start
November 12, 2019
Primary Completion
June 16, 2022
Study Completion
June 16, 2022
Last Updated
April 28, 2023
Results First Posted
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share