NCT03219320: DPN

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

Completed Phase 2 Results posted Last updated 9 June 2020

What this trial tests

Phase 2 trial testing NYX-2925 in Diabetic Peripheral Neuropathy in 301 participants. Completed in 2 November 2018.

Timeline

27 June 2017

Primary endpoint
2 November 2018

2 November 2018

Quick facts

Lead sponsor	Aptinyx
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	301
Start date	27 June 2017
Primary completion	2 November 2018
Estimated completion	2 November 2018
Sites	35 locations across United States

Drugs / interventions tested

• NYX-2925 — full drug profile →
• Placebo

Conditions studied

• Diabetic Peripheral Neuropathy — all drugs for Diabetic Peripheral Neuropathy →

Sponsor

Aptinyx — full company profile →

Who can join

Adults 18 to 75, any sex, with Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numeric Rating Scale (NRS) Average Pain Intensity Primary · From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)

Change in the NRS score assessing average pain intensity in the past 24 hours; 0=no pain, 10=worst pain imaginable

Group	Value	95% CI
NYX-2925 200 mg QD	-1.50	± 0.19
NYX-2025 50 mg QD	-1.61	± 0.19
NYX-2925 10 mg QD	-1.15	± 0.19
Placebo QD	-1.23	± 0.19

Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline Secondary · baseline to week 4

Change in the NRS score assessing average pain intensity in the past 24 hours for patients who did not use a concomitant medication at baseline; 0=no pain, 10=worst pain imaginable

Group	Value	95% CI
NYX-2925 200 mg QD	-1.55	± 0.28
NYX-2025 50 mg QD	-1.62	± 0.26
NYX-2925 10 mg QD	-1.42	± 0.29
Placebo QD	-1.03	± 0.29

Numeric Rating Scale (NRS) Average Pain Intensity in Subjects With DPN >= 4 Years Secondary · baseline to week 4

Change in the NRS score assessing average pain intensity in the past 24 hours in patients with DPN \>=4 years; 0=no pain, 10=worst pain imaginable

Group	Value	95% CI
NYX-2925 200 mg QD	-1.19	± 0.27
NYX-2025 50 mg QD	-1.93	± 0.31
NYX-2925 10 mg QD	-1.00	± 0.29
Placebo QD	-0.72	± 0.27

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 4). The protocol required adverse events to be followed to resolution of the adverse event.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NYX-2925 200 mg QD

Serious: 0/75 (0%)

Deaths: 0/75

NYX-2925 50 mg QD

Serious: 0/77 (0%)

Deaths: 0/77

NYX-2925 10 mg QD

Serious: 0/77 (0%)

Deaths: 0/77

Placebo QD

Serious: 1/72 (1%)

Deaths: 0/72

Serious adverse events (1 terms)

Reaction	System	NYX-2925 200 mg QD	NYX-2925 50 mg QD	NYX-2925 10 mg QD	Placebo QD
Hepatobiliary disorders	Hepatobiliary disorders	—	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	NYX-2925 200 mg QD	NYX-2925 50 mg QD	NYX-2925 10 mg QD	Placebo QD
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—

Most-reported serious reactions: Hepatobiliary disorders.

Data from ClinicalTrials.gov NCT03219320 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting NMDA Receptors at the Neurovascular Unit: Past and Future Treatments for Central Nervous System Diseases.
   Seillier C, Lesept F, Toutirais O, Potzeha F, et al · · 2022 · cited 26× · PMID 36142247 · DOI 10.3390/ijms231810336
2. NMDAR activation regulates the daily rhythms of sleep and mood.
   Burgdorf JS, Vitaterna MH, Olker CJ, Song EJ, et al · · 2019 · cited 21× · PMID 31504971 · DOI 10.1093/sleep/zsz135