NCT04146896

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Aptinyx · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	NYX-2925 50 mg	NYX-2925 administered orally
DRUG	Placebo	Placebo administered orally

Timeline

• Start date: 2019-11-12
• Primary completion: 2022-02-23
• Completion: 2022-02-23
• First posted: 2019-10-31
• Last updated: 2023-04-28
• Results posted: 2023-04-28

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study