Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147858
• Other study ID #: NYX-2925-2005
• Status: Completed
• Phase: Phase 2
• Start date: November 12, 2019
• Est. completion date: June 16, 2022

Study information

• Verified date: April 2023
• Source: Aptinyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• NYX-2925
NYX-2925 administered orally
• Placebo
Placebo administered orally

Locations

Country	Name	City	State
United States	Aptinyx Clinical Site	Alpharetta	Georgia
United States	Aptinyx Clinical Site	Austin	Texas
United States	Aptinyx Clinical Site	Bellevue	Washington
United States	Aptinyx Clinical Site	Brooklyn	New York
United States	Aptinyx Clinical Site	Chicago	Illinois
United States	Aptinyx Clinical Site	Cincinnati	Ohio
United States	Aptinyx Clinical Site	Culver City	California
United States	Aptinyx Clinical Site	Danville	Virginia
United States	Aptinyx Clinical Site	Duncansville	Pennsylvania
United States	Aptinyx Clinical Site	Evansville	Indiana
United States	Aptinyx Clinical Site	Fernandina Beach	Florida
United States	Aptinyx Clinical Site	Flossmoor	Illinois
United States	Aptinyx Clinical Site	Fresno	California
United States	Aptinyx Clinical Site	Gurnee	Illinois
United States	Aptinyx Clinical Site	Hazelwood	Missouri
United States	Aptinyx Clinical Site	Houston	Texas
United States	Aptinyx Clinical Site	Jacksonville	Florida
United States	Aptinyx Clinical Site	Jacksonville	Florida
United States	Aptinyx Clinical Site	Lady Lake	Florida
United States	Aptinyx Clinical Site	Las Vegas	Nevada
United States	Aptinyx Clinical Site	Memphis	Tennessee
United States	Aptinyx Clinical Site	Miami	Florida
United States	Aptinyx Clinical Site	New York	New York
United States	Aptinyx Clinical Site	New York	New York
United States	Aptinyx Clinical Site	Newton	Kansas
United States	Aptinyx Clinical Site	Oklahoma City	Oklahoma
United States	Aptinyx Clinical Site	Omaha	Nebraska
United States	Aptinyx Clinical Site	Orange	California
United States	Aptinyx Clinical Site	Orlando	Florida
United States	Aptinyx Clinical Site	Palmetto Bay	Florida
United States	Aptinyx Clinical Site	Phoenix	Arizona
United States	Aptinyx Clinical Site	Prairie Village	Kansas
United States	Aptinyx Clinical Site	Redlands	California
United States	Aptinyx Clinical Site	Roslindale	Massachusetts
United States	Aptinyx Clinical Site	Skokie	Illinois
United States	Aptinyx Clinical Site	Staten Island	New York
United States	Aptinyx Clinical Site	Temecula	California
United States	Aptinyx Clinical Site	Torrance	California
United States	Aptinyx Clinical Site	West Des Moines	Iowa
United States	Aptinyx Clinical Site	Wichita	Kansas
United States	Aptinyx Clinical Site	Williamsville	New York
United States	Aptinyx Clinical Site	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Aptinyx	Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Week 12
Secondary	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.	Week 12
Secondary	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).	Week 12
Secondary	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)	Week 12
Secondary	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	Week 12
Secondary	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.	Week 12
Secondary	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	Week 12
Secondary	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.	Week 12
Secondary	Use of Rescue Medication	The number of subjects using rescue medication.	Week 12