Clinical trial NCT04146896: Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Aptinyx
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2019-10-31
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to receive either placebo or NYX-2925.
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

Detailed description: This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy.

The study will be a 13- to 16-week study, including 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 diabetic peripheral neuropathy of symmetrical nature in lower extremities for ≥4 years and reports at least moderate pain over the last week
* Stable diabetic and protocol allowed medication 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: Pain Intensity Numeric Rating Scale (NRS) Score
timeFrame: Week 12
Secondary outcomes:
measure: Daily Sleep Interference Scale (DSIS) Score
timeFrame: Week 12
measure: Patient Global Impression of Change (PGI-C)
timeFrame: Week 12
measure: Number of Subjects Achieving ≥30% Pain Reduction
timeFrame: Week 12
measure: Number of Subjects Achieving ≥50% Reduction
timeFrame: Week 12
measure: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score
timeFrame: Week 12
measure: Use of Rescue Medication
timeFrame: Week 12
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Aptinyx Clinical Site
state: California
city: Irvine
country: United States
facility: Aptinyx Clinical Site
state: California
city: Lomita
country: United States
facility: Aptinyx Clinical Site
state: California
city: Los Angeles
country: United States
facility: Aptinyx Clinical Site
state: California
city: Norco
country: United States
facility: Aptinyx Clinical Site
state: California
city: Pomona
country: United States
facility: Aptinyx Clinical Site
state: California
city: Santa Ana
country: United States
facility: Aptinyx Clinical Site
state: California
city: Tustin
country: United States
facility: Aptinyx Clinical Site
state: California
city: Brandon
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Clearwater
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Greenacres City
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Miami
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: New Port Richey
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Tampa
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Tampa
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Winter Haven
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Winter Park
country: United States
facility: Aptinyx Clinical Site
state: Florida
city: Decatur
country: United States
facility: Aptinyx Clinical Site
state: Georgia
city: Marietta
country: United States
facility: Aptinyx Clinical Site
state: Georgia
city: Blackfoot
country: United States
facility: Aptinyx Clinical Site
state: Idaho
city: Flossmoor
country: United States
facility: Aptinyx Clinical Site
state: Illinois
city: Rochester
country: United States
facility: Aptinyx Clinical Site
state: Michigan
city: Hazelwood
country: United States
facility: Aptinyx Clinical Site
state: Missouri
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: Rochester
country: United States
facility: Aptinyx Clinical Site
state: New York
city: Greenville
country: United States
facility: Aptinyx Clinical Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Aptinyx Clinical Site
state: North Carolina
city: Duncansville
country: United States
facility: Aptinyx Clinical Site
state: Pennsylvania
city: Houston
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Mesquite
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: Plano
country: United States
facility: Aptinyx Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Aptinyx Clinical Site
state: Texas
Study officials:
References: