NCT03219320

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

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose 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: 301 (actual)
• Sponsor: Aptinyx · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of multiple dose levels of NYX-2925 versus placebo in treating the neuropathic pain associated with Diabetic Peripheral Neuropathy.

Detailed description

This is a randomized, double-blind, parallel-group, placebo-controlled, multiple-dose 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 6 to 9-week study, including a 1 to 4-week (dependent on duration of washout period) Screening Period, followed by a 4-week double-blind, randomized, placebo-controlled Treatment Period, and a 1-week Follow Up Period. Subjects eligible for the study will randomize to receive either NYX-2925 or placebo for 4 weeks.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	NYX-2925	NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
DRUG	Placebo	Matching Placebo capsules.

Timeline

• Start date: 2017-06-27
• Primary completion: 2018-11-02
• Completion: 2018-11-02
• First posted: 2017-07-17
• Last updated: 2020-06-09
• Results posted: 2020-06-09

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study