Clinical trial NCT04147858: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Lead sponsor: Aptinyx
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2019-11-01
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Mean Numerical Rating Scale (NRS) Score
timeFrame: Week 12
Secondary outcomes:
measure: Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12
timeFrame: Week 12
measure: Daily Sleep Interference (DSIS) Score
timeFrame: Week 12
measure: Number of Subjects Achieving ≥30% Pain Reduction
timeFrame: Week 12
measure: Number of Subjects Achieving ≥50% Pain Reduction
timeFrame: Week 12
measure: Fibromyalgia Impact Questionnaire-Revised (FIQR) Score
timeFrame: Week 12
measure: Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score
timeFrame: Week 12
measure: Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score
timeFrame: Week 12
measure: Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score
timeFrame: Week 12
measure: Use of Rescue Medication
timeFrame: Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Aptinyx Clinical Site
state: Arizona
city: Culver City
country: United States
facility: Aptinyx Clinical Site
state: California
city: Fresno
country: United States
facility: Aptinyx Clinical Site
state: California
city: Orange
country: United States
facility: Aptinyx Clinical Site
state: California
city: Redlands
country: United States
facility: Aptinyx Clinical Site
state: California
city: Temecula
country: United States
facility: Aptinyx Clinical Site
state: California
city: Torrance
country: United States
facility: Aptinyx Clinical Site
state: California
city: Fernandina Beach
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Lady Lake
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Orlando
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Palmetto Bay
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Winter Park
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Alpharetta
country: United States
facility: Aptinyx Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Aptinyx Clinical Site
state: Illinois
city: Flossmoor
country: United States
facility: Aptinyx Clinical Site
state: Illinois
city: Gurnee
country: United States
facility: Aptinyx Clinical Site
state: Illinois
city: Skokie
country: United States
facility: Aptinyx Clinical Site
state: Illinois
city: Evansville
country: United States
facility: Aptinyx Clinical Site
state: Indiana
city: West Des Moines
country: United States
facility: Aptinyx Clinical Site
state: Iowa
city: Newton
country: United States
facility: Aptinyx Clinical Site
state: Kansas
city: Prairie Village
country: United States
facility: Aptinyx Clinical Site
state: Kansas
city: Wichita
country: United States
facility: Aptinyx Clinical Site
state: Kansas
city: Roslindale
country: United States
facility: Aptinyx Clinical Site
state: Massachusetts
city: Hazelwood
country: United States
facility: Aptinyx Clinical Site
state: Missouri
city: Omaha
country: United States
facility: Aptinyx Clinical Site
state: Nebraska
city: Las Vegas
country: United States
facility: Aptinyx Clinical Site
state: Nevada
city: Brooklyn
country: United States
facility: Aptinyx Clinical Site
state: New York
city: New York
country: United States
facility: Aptinyx Clinical Site
state: New York
city: New York
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Staten Island
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Williamsville
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Cincinnati
country: United States
facility: Aptinyx Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Aptinyx Clinical Site
state: Oklahoma
city: Duncansville
country: United States
facility: Aptinyx Clinical Site
state: Pennsylvania
city: Memphis
country: United States
facility: Aptinyx Clinical Site
state: Tennessee
city: Austin
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Houston
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Danville
country: United States
facility: Aptinyx Clinical Site
state: Virginia
city: Bellevue
country: United States
facility: Aptinyx Clinical Site
state: Washington
Study officials:
References: