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

• ClinicalTrials.gov Identifier: NCT04146896
• Recruitment Status: Recruiting
• First Posted: October 31, 2019
• Last Update Posted: December 18, 2019
• Sponsor: Aptinyx
• Collaborator: Syneos Health
• Information provided by (Responsible Party): Aptinyx

Study Description

Brief Summary:

To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

Condition or disease	Intervention/treatment	Phase
Diabetic Peripheral Neuropathic Pain	Drug: NYX-2925 50 mg; Drug: Placebo	Phase 2

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 15-18 weeks in duration, including a 1-4 week screening period (dependent upon duration of analgesic medication washout period), followed by a 14 week double-blind, randomized, placebo controlled treatment period. Subjects eligible for the study will receive either NYX-2925 or placebo during the treatment period. All subjects will receive placebo at some point during the treatment period.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized to receive either placebo or NYX-2925. All subjects will receive placebo at some point during the study.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Randomization algorithm, randomization allocation, allocation to study drug or placebo, timing for primary endpoints.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: November 12, 2019
• Estimated Primary Completion Date: November 2020
• Estimated Study Completion Date: November 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: NYX-2925; NYX-2925 50 mg	Drug: NYX-2925 50 mg; NYX-2925 administered orally. At some point in the study, all subjects will receive placebo.
Placebo Comparator: Placebo; Placebo	Drug: Placebo; Placebo administered orally

Outcome Measures

Primary Outcome Measures :

1. NRS score [ Time Frame: Up to 14 weeks ]
   Change in the mean NRS score assessing average pain intensity in the past 24 hours from baseline.

Secondary Outcome Measures :

1. Daily Sleep Interference Scale (DSIS) score [ Time Frame: Up to 14 weeks ]
   Change from baseline in the mean Daily Sleep Interference Scale (DSIS) score
2. Patient Global Impression of Change (PGI-C) [ Time Frame: Up to 14 weeks ]
   Patient Global Impression of Change (PGI-C).
3. Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Up to 14 weeks ]
   Percentage of subjects achieving ≥30% pain reduction in the mean NRS average pain intensity from baseline.
4. Norfolk Quality of Life - Diabetic Neuropathy questionnaire [ Time Frame: Up to 14 weeks ]
   Change from baseline in the Norfolk Quality of Life - Diabetic Neuropathy questionnaire

Other Outcome Measures:

1. Other Endpoints [ Time Frame: Up to 14 weeks ]
   Adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. An Institutional Review Board approved written informed consent and privacy language (Health Insurance Portability and Accountability Act (HIPAA)) authorization must be obtained from the subject prior to performing any study-related procedures.
2. Consent to being included in a research subject database.
3. ≥18 and ≤75 years of age.
4. Type 2 Diabetes.
5. Score of ≥5 and ≤9 on the 11-point NRS for average neuropathic 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.
8. Diabetic peripheral neuropathy, of symmetrical nature and in lower extremities, for ≥4 years.
9. Pain due to diabetic peripheral neuropathy, of symmetrical nature and in lower extremities, for ≥2 years.
10. Score of ≥3 on the Physical Assessment Total Score of the Michigan Neuropathy Screening Instrument.
11. Body mass index ≤40 kg/m2.
12. Absence of impaired hepatic function
13. Calculated creatinine clearance ≥60 mL/minute/1.73 m2 (Cockcroft-Gault formula).
14. Fasting triglycerides <600 mg/dL.

Inclusion Criteria: Randomization Daily pain scores and diary compliance will be transferred into the interactive response technology system, which will be used to assess the criteria for randomization. Subjects whose mean of the daily average pain intensity score during the preceding 7 (±1) days is within the protocol-defined algorithm and with adequate compliance with daily diary completion will be eligible for randomization.

Exclusion Criteria:

Subjects who meet ANY of the following criteria will be excluded from the study:

1. Current diagnosis of a major psychiatric disorder
2. Pain that cannot be clearly differentiated from, or could interfere with, the assessment of peripheral diabetic neuropathy.
3. Neurologic disorders unrelated to diabetic neuropathy that could interfere with reporting of pain due to diabetic neuropathy.
4. History of hypoglycemia that disturbed consciousness, or ketoacidosis requiring hospitalization within the past 3 months.
5. History of severe renal impairment.
6. Known history of significant cardiovascular condition
7. Pulse rate <45 bpm or >90 bpm.
8. History of Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, or a history of seizures, epilepsy, or stroke.
9. Ongoing clinically significant infectious disease.
10. Concomitant use of protocol specified prohibited medications.
11. History of a substance use disorder.
12. Positive urine drug screen or positive breathalyzer test for alcohol
13. Sensitivity or allergy to, or concomitant use of N-methyl-D-aspartate receptor ligands
14. Use of NMDAR-binding drugs within 30 days prior to dosing or during the study.
15. Amputations of lower extremities (toe(s) amputation is allowed).
16. Meets the criteria for suicidal intent, plan and/or behavior.

Contacts and Locations

Contacts

Contact: Aptinyx Clinical Development; 847 871 0377 ext 1; clinicalstudies@aptinyx.com

Locations

United States, Arizona

Aptinyx Clinical Site; Recruiting

Chandler, Arizona, United States, 85224

Aptinyx Clinical Site; Recruiting

Glendale, Arizona, United States, 85306

Aptinyx Clinical Site; Recruiting

Mesa, Arizona, United States, 85206

Aptinyx Clinical Site; Recruiting

Phoenix, Arizona, United States, 85050

Aptinyx Clinical Site; Recruiting

Tucson, Arizona, United States, 85741

United States, California

Aptinyx Clinical Site; Recruiting

Carlsbad, California, United States, 92008

Aptinyx Clinical Site; Recruiting

Santa Rosa, California, United States, 95405

United States, Florida

Aptinyx Clinical Site; Recruiting

Pinellas Park, Florida, United States, 33781

United States, Indiana

Aptinyx Clinical Site; Recruiting

Evansville, Indiana, United States, 47714

United States, Minnesota

Aptinyx Clinical Site; Recruiting

Richfield, Minnesota, United States, 55423

United States, Missouri

Aptinyx Clinical Site; Recruiting

Saint Louis, Missouri, United States, 63141

United States, Ohio

Aptinyx Clinical Site; Recruiting

Cincinnati, Ohio, United States, 45236

Aptinyx Clinical Site; Recruiting

Columbus, Ohio, United States, 43212

United States, Oklahoma

Aptinyx Clinical Site; Recruiting

Oklahoma City, Oklahoma, United States, 73111

United States, South Carolina

Aptinyx Clinical Site; Recruiting

Greer, South Carolina, United States, 29651

United States, Texas

Aptinyx Clinical Site; Recruiting

Dallas, Texas, United States, 75234

Aptinyx Clinical Site; Recruiting

Plano, Texas, United States, 75093

Aptinyx Clinical Site; Recruiting

San Antonio, Texas, United States, 78229

United States, Utah

Aptinyx Clinical Site; Recruiting

Murray, Utah, United States, 84123

Sponsors and Collaborators

Aptinyx

Syneos Health

More Information

• Responsible Party: Aptinyx
• ClinicalTrials.gov Identifier: NCT04146896
• Other Study ID Numbers: NYX-2925-2008
• First Posted: October 31, 2019
• Last Update Posted: December 18, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms