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

NCT03219320 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NYX-2925-2001
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 35

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathy

Keywords

Type 2 Diabetes; Neuropathic Pain; Peripheral Nervous System

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) Average Pain Intensity

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

  From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)

Secondary Outcomes (1)

• Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline

  baseline to week 4

Study Arms (2)

Placebo Oral Capsule

PLACEBO COMPARATOR

Up to 300 subjects: Placebo

Drug: Placebo

NYX-2925

EXPERIMENTAL

Up to 300 subjects: Multiple dose levels of NYX-2925 daily for 28 days

Drug: NYX-2925

Interventions

NYX-2925 DRUG

NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

NYX-2925

Placebo DRUG

Matching Placebo capsules.

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board-approved written informed consent and privacy language (Health Insurance Portability and Accountability Act) authorization must be obtained from the subject prior to performing any study-related procedures.
• Subjects who consent to being included in a subject registry database.
• Male and female subjects ≥18 and ≤75 years of age.
• Subjects with a diagnosis of Type 2 diabetes.
• Subjects with a score of ≥4 and ≤9 on the 11-point numeric rating scale (NRS) for average pain intensity over the past 24 hours at Visit 1.
• Hemoglobin A1c (HbA1c) ≤11% (measured at Visit 1).
• Stable use of diabetic medications beginning 1 month prior to Visit 1 (Adequate glycemic control with only diet and exercise is also permitted.).
• Subjects with diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months to ≤10 years, and diagnosed by a score of ≥3 on Michigan Neuropathy Screening Instrument.
• Body mass index of \<40 kg/m\^2
• Calculated creatinine clearance of ≥60 mL/minute (Cockcroft-Gault formula).
• Clinical laboratory values must be within normal limits or deemed not clinically significant by the investigator and sponsor-designated medical monitor.

You may not qualify if:

• Subjects who have a current diagnosis of major psychiatric disorder (including schizophrenia, bipolar disorder, or panic disorder), including those who have required an antipsychotic or mood stabilizer (e.g., lithium, carbamazepine, valproate) for a psychiatric condition in the past year, or subjects who have had a major depressive episode (MDE) in the past 6 months. Subjects with major depressive disorder (MDD) or generalized anxiety disorder (GAD) who have been on stable medications for the past 3 months (and are expected to remain stable for the duration of the trial) and whose condition is currently well-controlled may be included.
• Subjects who have pain that cannot be clearly differentiated from, or could interfere with the assessment of peripheral diabetic neuropathy, as measured by the Masquerading Disorders Tool at Visit 1.
• Neurologic disorders unrelated to diabetic neuropathy (e.g., phantom limb from amputation), skin condition in the area of neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis) that, in the judgment of the investigators, could interfere with reporting of pain due to diabetic neuropathy.
• History of hypoglycemia that disturbed consciousness, or ketoacidosis requiring hospitalization within past 3 months.
• Subjects with history of severe renal impairment.
• Impaired hepatic function.
• Known history of significant cardiovascular condition.
• History of Huntington's disease, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, or a history of seizures, epilepsy, or strokes.
• HIV infection, hepatitis, or other ongoing infectious disease that the investigator considers clinically significant.
• Concomitant use of antiepileptic drugs, non-steroidal anti-inflammatory drugs (except cardiac preventive acetylsalicylic acid), opioids, muscle relaxants, dextromethorphan (except low dose intermittent use for cough), tramadol, topical lidocaine, topical capsaicin, and selective norepinephrine reuptake inhibitors. Subjects are allowed to enter with a maximum of 1 allowed analgesic medication for neuropathic pain that has been taken at stable dose for at least 1 month (30 days) prior to Visit 1. Allowed analgesics may not be N-methyl-D-aspartate receptor ligands, must be non-opioid and non-sedative and must not interfere with subjects' pain reporting. Tricyclic antidepressants may be continued if designated as the single analgesic medication for the treatment of pain.
• Sensitivity to, allergy to, or concomitant use of N-methyl-D-aspartate receptor ligands including ketamine, amantadine, dextromethorphan (except low dose intermittent use for cough), memantine, methadone, dextropropoxyphene, and/or ketobemidone.
• Amputations of lower extremities (toe amputation is allowed).
• Any condition, including serious medical conditions that could interfere with the ability of the subject to participate in the study or could confound study assessments.
• Subjects who meet the criteria for suicidal intent, plan and/or behavior by scoring 3 or 4 on Questions 2 or 13, or 2 or higher on any Questions 1a (only if 1b is coded YES), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 14 based on the Sheehan - Suicidality Tracking Scale at Visit 1 or Visit 2.

Sponsors & Collaborators

• Aptinyx: lead
• Syneos Health: collaborator

Study Sites (35)

Aptinyx Clinical Site

Phoenix, Arizona, 85053, United States

Location

Aptinyx Clinical Site

Anaheim, California, 92801, United States

Location

Aptinyx Clinical Site

Fresno, California, 93710, United States

Location

Aptinyx Clinical Site

Norco, California, 92860, United States

Location

Aptinyx Clinical Site

Santa Monica, California, 90404, United States

Location

Aptinyx Clinical Site

Tustin, California, 92480, United States

Location

Aptinyx Clinical Site

New London, Connecticut, 06320, United States

Location

Aptinyx Clinical Site

Bradenton, Florida, 34201, United States

Location

Aptinyx Clinical Site

Brandon, Florida, 33511, United States

Location

Aptinyx Clinical Site

Fort Myers, Florida, 33912, United States

Location

Aptinyx Clinical Site

Hallandale, Florida, 33009, United States

Location

Aptinyx Clinical Site

Jupiter, Florida, 33458, United States

Location

Aptinyx Clinical Site

Miami, Florida, 33012, United States

Location

Aptinyx Clinical Site

Miami, Florida, 33126, United States

Location

Aptinyx Clinical Site

Miami, Florida, 33175, United States

Location

Aptinyx Clinical Site

Ocoee, Florida, 34761, United States

Location

Aptinyx Clinical Site

Orlando, Florida, 32801, United States

Location

Aptinyx Clinical Site

Orlando, Florida, 32806, United States

Location

Aptinyx Clinical Site

Tampa, Florida, 33603, United States

Location

Aptinyx Clinical Site

West Palm Beach, Florida, 33401, United States

Location

Aptinyx Clinical Site

Columbus, Georgia, 31904, United States

Location

Aptinyx Clinical Site

Decatur, Georgia, 30033, United States

Location

Aptinyx Clinical Site

Meridian, Idaho, 83642, United States

Location

Aptinyx Clinical Site

Flossmoor, Illinois, 60422, United States

Location

Aptinyx Clinical Site

Hazelwood, Missouri, 63042, United States

Location

Aptinyx Clinical Site

Berlin, New Jersey, 08009, United States

Location

Aptinyx Clinical Site

Rochester, New York, 14618, United States

Location

Aptinyx Clinical Site

Dayton, Ohio, 45439, United States

Location

Aptinyx Clinical Site

Knoxville, Tennessee, 37909, United States

Location

Aptinyx Clinical Site

Memphis, Tennessee, 38119, United States

Location

Aptinyx Clinical Site

Tullahoma, Tennessee, 37388, United States

Location

Aptinyx Clinical Site

Austin, Texas, 78731, United States

Location

Aptinyx Clinical Site

Houston, Texas, 77058, United States

Location

Aptinyx Clinical Site

Plano, Texas, 75024, United States

Location

Aptinyx Clinical Site

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Neuralgia

Interventions

NYX-2925

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Aptinyx Clinical Development
• Organization: Aptinyx

clinicalstudies@aptinyx.com

847-871-0377

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment arms, dose levels, and randomization algorithm are masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive placebo or NYX-2925.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 17, 2017
• Study Start: June 27, 2017
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

US (35)