Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)

NCT ID: NCT04146896

Last Updated: 2023-04-28

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2022-02-23

Brief Summary

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

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 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.

Conditions

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Diabetic Peripheral Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to receive either placebo or NYX-2925.
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

NYX-2925 50 mg

Group Type EXPERIMENTAL

NYX-2925 50 mg

Intervention Type DRUG

NYX-2925 administered orally

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered orally

Interventions

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NYX-2925 50 mg

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 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
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

Fresno, California, United States

Site Status

Aptinyx Clinical Site

Irvine, California, United States

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Aptinyx Clinical Site

Lomita, California, United States

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Aptinyx Clinical Site

Los Angeles, California, United States

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Aptinyx Clinical Site

Norco, California, United States

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Aptinyx Clinical Site

Pomona, California, United States

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Aptinyx Clinical Site

Santa Ana, California, United States

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Aptinyx Clinical Site

Tustin, California, United States

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Aptinyx Clinical Site

Brandon, Florida, United States

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Aptinyx Clinical Site

Clearwater, Florida, United States

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Aptinyx Clinical Site

Greenacres City, Florida, United States

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Aptinyx Clinical Site

Miami, Florida, United States

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Aptinyx Clinical Site

Miami, Florida, United States

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Aptinyx Clinical Site

New Port Richey, Florida, United States

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Aptinyx Clinical Site

Tampa, Florida, United States

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Aptinyx Clinical Site

Tampa, Florida, United States

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Aptinyx Clinical Site

Winter Haven, Florida, United States

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Aptinyx Clinical Site

Winter Park, Florida, United States

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Aptinyx Clinical Site

Decatur, Georgia, United States

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Aptinyx Clinical Site

Marietta, Georgia, United States

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Aptinyx Clinical Site

Blackfoot, Idaho, United States

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Aptinyx Clinical Site

Flossmoor, Illinois, United States

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Aptinyx Clinical Site

Rochester, Michigan, United States

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Aptinyx Clinical Site

Hazelwood, Missouri, 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

Rochester, New York, United States

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Aptinyx Clinical Site

Greenville, North Carolina, United States

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Aptinyx Clinical Site

Winston-Salem, North Carolina, United States

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Aptinyx Clinical Site

Duncansville, Pennsylvania, United States

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Aptinyx Clinical Site

Houston, Texas, United States

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Aptinyx Clinical Site

Mesquite, Texas, United States

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Aptinyx Clinical Site

Plano, Texas, United States

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Aptinyx Clinical Site

San Antonio, Texas, 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-2925-2008

Identifier Type: -

Identifier Source: org_study_id

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