Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04147858
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aptinyx
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia
Additional Details

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.

Arms & Interventions

Arms

Experimental: NYX-2925 50 mg

NYX-2925 50 mg administered orally.

Experimental: NYX-2925 100 mg

NYX-2925 100 mg administered orally.

Placebo Comparator: Placebo

Placebo administered orally.

Interventions

Drug: - NYX-2925

NYX-2925 administered orally

Drug: - Placebo

Placebo administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aptinyx Clinical Site, Phoenix, Arizona

Status

Recruiting

Address

Aptinyx Clinical Site

Phoenix, Arizona, 85012

Aptinyx Clinical Site, Culver City, California

Status

Recruiting

Address

Aptinyx Clinical Site

Culver City, California, 90230

Aptinyx Clinical Site, Fresno, California

Status

Recruiting

Address

Aptinyx Clinical Site

Fresno, California, 93710

Aptinyx Clinical Site, Orange, California

Status

Recruiting

Address

Aptinyx Clinical Site

Orange, California, 92868

Aptinyx Clinical Site, Redlands, California

Status

Recruiting

Address

Aptinyx Clinical Site

Redlands, California, 92374

Aptinyx Clinical Site, Temecula, California

Status

Recruiting

Address

Aptinyx Clinical Site

Temecula, California, 92591

Aptinyx Clinical Site, Torrance, California

Status

Recruiting

Address

Aptinyx Clinical Site

Torrance, California, 90502

Aptinyx Clinical Site, Fernandina Beach, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Fernandina Beach, Florida, 32034

Aptinyx Clinical Site, Jacksonville, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Jacksonville, Florida, 32224

Aptinyx Clinical Site, Jacksonville, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Jacksonville, Florida, 32256

Aptinyx Clinical Site, Lady Lake, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Lady Lake, Florida, 32159

Aptinyx Clinical Site, Miami, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Miami, Florida, 33165

Site Contact

Aptinyx C Site

[email protected]

847 871 0377

Aptinyx Clinical Site, Orlando, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Orlando, Florida, 32801

Aptinyx Clinical Site, Palmetto Bay, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Palmetto Bay, Florida, 33157

Aptinyx Clinical Site, Winter Park, Florida

Status

Recruiting

Address

Aptinyx Clinical Site

Winter Park, Florida, 32789

Aptinyx Clinical Site, Alpharetta, Georgia

Status

Recruiting

Address

Aptinyx Clinical Site

Alpharetta, Georgia, 30022

Aptinyx Clinical Site, Chicago, Illinois

Status

Recruiting

Address

Aptinyx Clinical Site

Chicago, Illinois, 60607

Aptinyx Clinical Site, Flossmoor, Illinois

Status

Recruiting

Address

Aptinyx Clinical Site

Flossmoor, Illinois, 60422

Aptinyx Clinical Site, Gurnee, Illinois

Status

Recruiting

Address

Aptinyx Clinical Site

Gurnee, Illinois, 60031

Aptinyx Clinical Site, Skokie, Illinois

Status

Recruiting

Address

Aptinyx Clinical Site

Skokie, Illinois, 60076

Aptinyx Clinical Site, Evansville, Indiana

Status

Recruiting

Address

Aptinyx Clinical Site

Evansville, Indiana, 47714

Aptinyx Clinical Site, West Des Moines, Iowa

Status

Recruiting

Address

Aptinyx Clinical Site

West Des Moines, Iowa, 50265

Aptinyx Clinical Site, Newton, Kansas

Status

Recruiting

Address

Aptinyx Clinical Site

Newton, Kansas, 67114

Aptinyx Clinical Site, Prairie Village, Kansas

Status

Recruiting

Address

Aptinyx Clinical Site

Prairie Village, Kansas, 66208

Aptinyx Clinical Site, Wichita, Kansas

Status

Recruiting

Address

Aptinyx Clinical Site

Wichita, Kansas, 67205

Aptinyx Clinical Site, Roslindale, Massachusetts

Status

Recruiting

Address

Aptinyx Clinical Site

Roslindale, Massachusetts, 02131

Aptinyx Clinical Site, Hazelwood, Missouri

Status

Recruiting

Address

Aptinyx Clinical Site

Hazelwood, Missouri, 63042

Aptinyx Clinical Site, Omaha, Nebraska

Status

Recruiting

Address

Aptinyx Clinical Site

Omaha, Nebraska, 68114

Aptinyx Clinical Site, Las Vegas, Nevada

Status

Recruiting

Address

Aptinyx Clinical Site

Las Vegas, Nevada, 89102

Aptinyx Clinical Site, Brooklyn, New York

Status

Recruiting

Address

Aptinyx Clinical Site

Brooklyn, New York, 11235

Aptinyx Clinical Site, New York, New York

Status

Recruiting

Address

Aptinyx Clinical Site

New York, New York, 10017

Aptinyx Clinical Site, New York, New York

Status

Recruiting

Address

Aptinyx Clinical Site

New York, New York, 10036

Aptinyx Clinical Site, Staten Island, New York

Status

Recruiting

Address

Aptinyx Clinical Site

Staten Island, New York, 10312

Aptinyx Clinical Site, Williamsville, New York

Status

Recruiting

Address

Aptinyx Clinical Site

Williamsville, New York, 14221

Aptinyx Clinical Site, Cincinnati, Ohio

Status

Recruiting

Address

Aptinyx Clinical Site

Cincinnati, Ohio, 45219

Aptinyx Clinical Site, Oklahoma City, Oklahoma

Status

Recruiting

Address

Aptinyx Clinical Site

Oklahoma City, Oklahoma, 73106

Aptinyx Clinical Site, Duncansville, Pennsylvania

Status

Recruiting

Address

Aptinyx Clinical Site

Duncansville, Pennsylvania, 16635

Aptinyx Clinical Site, Memphis, Tennessee

Status

Recruiting

Address

Aptinyx Clinical Site

Memphis, Tennessee, 38119

Aptinyx Clinical Site, Austin, Texas

Status

Recruiting

Address

Aptinyx Clinical Site

Austin, Texas, 78737

Aptinyx Clinical Site, Houston, Texas

Status

Recruiting

Address

Aptinyx Clinical Site

Houston, Texas, 77077

Aptinyx Clinical Site, Danville, Virginia

Status

Recruiting

Address

Aptinyx Clinical Site

Danville, Virginia, 24541

Aptinyx Clinical Site, Bellevue, Washington

Status

Recruiting

Address

Aptinyx Clinical Site

Bellevue, Washington, 98007