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

NCT ID: NCT03219320

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-27
• Study Completion Date: 2018-11-02

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo Oral Capsule

Up to 300 subjects: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo capsules.

NYX-2925

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

Group Type: EXPERIMENTAL

NYX-2925

Intervention Type: DRUG

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

Interventions

NYX-2925

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

Intervention Type: DRUG

Placebo

Matching Placebo capsules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Subjects who consent to being included in a subject registry database.

3. Male and female subjects ≥18 and ≤75 years of age.

4. Subjects with a diagnosis of Type 2 diabetes.

5. 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.

6. Hemoglobin A1c (HbA1c) ≤11% (measured at Visit 1).

7. Stable use of diabetic medications beginning 1 month prior to Visit 1 (Adequate glycemic control with only diet and exercise is also permitted.).

8. 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.

9. Body mass index of <40 kg/m^2

10. Calculated creatinine clearance of ≥60 mL/minute (Cockcroft-Gault formula).

11. Clinical laboratory values must be within normal limits or deemed not clinically significant by the investigator and sponsor-designated medical monitor.

Exclusion Criteria

1. 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.

2. 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.

3. 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.

4. History of hypoglycemia that disturbed consciousness, or ketoacidosis requiring hospitalization within past 3 months.

5. Subjects with history of severe renal impairment.

6. Impaired hepatic function.

7. Known history of significant cardiovascular condition.

8. History of Huntington's disease, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, or a history of seizures, epilepsy, or strokes.

9. HIV infection, hepatitis, or other ongoing infectious disease that the investigator considers clinically significant.

10. 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.

11. 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.

12. Amputations of lower extremities (toe amputation is allowed).

13. 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.

14. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Aptinyx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aptinyx Clinical Site

Phoenix, Arizona, United States

Aptinyx Clinical Site

Anaheim, California, United States

Aptinyx Clinical Site

Fresno, California, United States

Aptinyx Clinical Site

Norco, California, United States

Aptinyx Clinical Site

Santa Monica, California, United States

Aptinyx Clinical Site

Tustin, California, United States

Aptinyx Clinical Site

New London, Connecticut, United States

Aptinyx Clinical Site

Bradenton, Florida, United States

Aptinyx Clinical Site

Brandon, Florida, United States

Aptinyx Clinical Site

Fort Myers, Florida, United States

Aptinyx Clinical Site

Hallandale, Florida, United States

Aptinyx Clinical Site

Jupiter, Florida, United States

Aptinyx Clinical Site

Miami, Florida, United States

Aptinyx Clinical Site

Miami, Florida, United States

Aptinyx Clinical Site

Miami, Florida, United States

Aptinyx Clinical Site

Ocoee, Florida, United States

Aptinyx Clinical Site

Orlando, Florida, United States

Aptinyx Clinical Site

Orlando, Florida, United States

Aptinyx Clinical Site

Tampa, Florida, United States

Aptinyx Clinical Site

West Palm Beach, Florida, United States

Aptinyx Clinical Site

Columbus, Georgia, United States

Aptinyx Clinical Site

Decatur, Georgia, United States

Aptinyx Clinical Site

Meridian, Idaho, United States

Aptinyx Clinical Site

Flossmoor, Illinois, United States

Aptinyx Clinical Site

Hazelwood, Missouri, United States

Aptinyx Clinical Site

Berlin, New Jersey, United States

Aptinyx Clinical Site

Rochester, New York, United States

Aptinyx Clinical Site

Dayton, Ohio, United States

Aptinyx Clinical Site

Knoxville, Tennessee, United States

Aptinyx Clinical Site

Memphis, Tennessee, United States

Aptinyx Clinical Site

Tullahoma, Tennessee, United States

Aptinyx Clinical Site

Austin, Texas, United States

Aptinyx Clinical Site

Houston, Texas, United States

Aptinyx Clinical Site

Plano, Texas, United States

Aptinyx Clinical Site

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NYX-2925-2001

Identifier Type: -

Identifier Source: org_study_id