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

Aptinyx

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: NYX-2925 50 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04146896

NYX-2925-2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 2 patient groups, including a placebo group

NYX-2925

Experimental group

Description:

NYX-2925 50 mg

Treatment:

Drug: NYX-2925 50 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo