Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

NCT ID: NCT04147858

Last Updated: 2023-04-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2022-06-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Randomization algorithm, randomization allocation, allocation to study drug or placebo.

Study Groups

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NYX-2925 50 mg

NYX-2925 50 mg administered orally.

Group Type EXPERIMENTAL

NYX-2925

Intervention Type DRUG

NYX-2925 administered orally

NYX-2925 100 mg

NYX-2925 100 mg administered orally.

Group Type EXPERIMENTAL

NYX-2925

Intervention Type DRUG

NYX-2925 administered orally

Placebo

Placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered orally

Interventions

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NYX-2925

NYX-2925 administered orally

Intervention Type DRUG

Placebo

Placebo administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Worldwide Clinical Trials

OTHER

Sponsor Role collaborator

Aptinyx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aptinyx Clinical Site

Phoenix, Arizona, United States

Site Status

Aptinyx Clinical Site

Culver City, California, United States

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Aptinyx Clinical Site

Fresno, California, United States

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Aptinyx Clinical Site

Orange, California, United States

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Aptinyx Clinical Site

Redlands, California, United States

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Aptinyx Clinical Site

Temecula, California, United States

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Aptinyx Clinical Site

Torrance, California, United States

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Aptinyx Clinical Site

Fernandina Beach, Florida, United States

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Aptinyx Clinical Site

Jacksonville, Florida, United States

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Aptinyx Clinical Site

Jacksonville, Florida, United States

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Aptinyx Clinical Site

Lady Lake, Florida, United States

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Aptinyx Clinical Site

Miami, Florida, United States

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Aptinyx Clinical Site

Orlando, Florida, United States

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Aptinyx Clinical Site

Palmetto Bay, Florida, United States

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Aptinyx Clinical Site

Winter Park, Florida, United States

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Aptinyx Clinical Site

Alpharetta, Georgia, United States

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Aptinyx Clinical Site

Chicago, Illinois, United States

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Aptinyx Clinical Site

Flossmoor, Illinois, United States

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Aptinyx Clinical Site

Gurnee, Illinois, United States

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Aptinyx Clinical Site

Skokie, Illinois, United States

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Aptinyx Clinical Site

Evansville, Indiana, United States

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Aptinyx Clinical Site

West Des Moines, Iowa, United States

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Aptinyx Clinical Site

Newton, Kansas, United States

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Aptinyx Clinical Site

Prairie Village, Kansas, United States

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Aptinyx Clinical Site

Wichita, Kansas, United States

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Aptinyx Clinical Site

Roslindale, Massachusetts, United States

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Aptinyx Clinical Site

Hazelwood, Missouri, United States

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Aptinyx Clinical Site

Omaha, Nebraska, United States

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Aptinyx Clinical Site

Las Vegas, Nevada, United States

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Aptinyx Clinical Site

Brooklyn, New York, United States

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Aptinyx Clinical Site

New York, New York, United States

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Aptinyx Clinical Site

New York, New York, United States

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Aptinyx Clinical Site

Staten Island, New York, United States

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Aptinyx Clinical Site

Williamsville, New York, United States

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Aptinyx Clinical Site

Cincinnati, Ohio, United States

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Aptinyx Clinical Site

Oklahoma City, Oklahoma, United States

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Aptinyx Clinical Site

Duncansville, Pennsylvania, United States

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Aptinyx Clinical Site

Memphis, Tennessee, United States

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Aptinyx Clinical Site

Austin, Texas, United States

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Aptinyx Clinical Site

Houston, Texas, United States

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Aptinyx Clinical Site

Danville, Virginia, United States

Site Status

Aptinyx Clinical Site

Bellevue, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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NYX-2925-2005

Identifier Type: -

Identifier Source: org_study_id

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