Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03219320
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219320
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Aptinyx

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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Drug: NYX-2925 Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to receive placebo or NYX-2925.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Treatment arms, dose levels, and randomization algorithm are masked.
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Oral Capsule
Up to 300 subjects: Placebo
Drug: Placebo
Matching Placebo capsules.

Experimental: NYX-2925
Up to 300 subjects: Multiple dose levels of NYX-2925 daily for 28 days
Drug: NYX-2925
NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).




Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) Average Pain Intensity [ Time Frame: 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


Secondary Outcome Measures :
  1. Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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) 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.

Inclusion Criteria: Randomization Daily pain scores and diary compliance will be transferred into the interactive response technology system, which will 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.

Waivers to the inclusion criteria will NOT be allowed.

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.

Waivers to the exclusion criteria will NOT be allowed.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219320


Locations
Layout table for location information
United States, Arizona
Aptinyx Clinical Site
Phoenix, Arizona, United States, 85053
United States, California
Aptinyx Clinical Site
Anaheim, California, United States, 92801
Aptinyx Clinical Site
Fresno, California, United States, 93710
Aptinyx Clinical Site
Norco, California, United States, 92860
Aptinyx Clinical Site
Santa Monica, California, United States, 90404
Aptinyx Clinical Site
Tustin, California, United States, 92480
United States, Connecticut
Aptinyx Clinical Site
New London, Connecticut, United States, 06320
United States, Florida
Aptinyx Clinical Site
Bradenton, Florida, United States, 34201
Aptinyx Clinical Site
Brandon, Florida, United States, 33511
Aptinyx Clinical Site
Fort Myers, Florida, United States, 33912
Aptinyx Clinical Site
Hallandale Beach, Florida, United States, 33009
Aptinyx Clinical Site
Jupiter, Florida, United States, 33458
Aptinyx Clinical Site
Miami, Florida, United States, 33012
Aptinyx Clinical Site
Miami, Florida, United States, 33126
Aptinyx Clinical Site
Miami, Florida, United States, 33175
Aptinyx Clinical Site
Ocoee, Florida, United States, 34761
Aptinyx Clinical Site
Orlando, Florida, United States, 32801
Aptinyx Clinical Site
Orlando, Florida, United States, 32806
Aptinyx Clinical Site
Tampa, Florida, United States, 33603
Aptinyx Clinical Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Aptinyx Clinical Site
Columbus, Georgia, United States, 31904
Aptinyx Clinical Site
Decatur, Georgia, United States, 30033
United States, Idaho
Aptinyx Clinical Site
Meridian, Idaho, United States, 83642
United States, Illinois
Aptinyx Clinical Site
Flossmoor, Illinois, United States, 60422
United States, Missouri
Aptinyx Clinical Site
Hazelwood, Missouri, United States, 63042
United States, New Jersey
Aptinyx Clinical Site
Berlin, New Jersey, United States, 08009
United States, New York
Aptinyx Clinical Site
Rochester, New York, United States, 14618
United States, Ohio
Aptinyx Clinical Site
Dayton, Ohio, United States, 45439
United States, Tennessee
Aptinyx Clinical Site
Knoxville, Tennessee, United States, 37909
Aptinyx Clinical Site
Memphis, Tennessee, United States, 38119
Aptinyx Clinical Site
Tullahoma, Tennessee, United States, 37388
United States, Texas
Aptinyx Clinical Site
Austin, Texas, United States, 78731
Aptinyx Clinical Site
Houston, Texas, United States, 77058
Aptinyx Clinical Site
Plano, Texas, United States, 75024
United States, Virginia
Aptinyx Clinical Site
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Aptinyx
Syneos Health
  Study Documents (Full-Text)

Documents provided by Aptinyx:
Study Protocol  [PDF] February 28, 2018
Statistical Analysis Plan  [PDF] December 14, 2018

Layout table for additonal information
Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT03219320    
Other Study ID Numbers: NYX-2925-2001
First Posted: July 17, 2017    Key Record Dates
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aptinyx:
Type 2 Diabetes
Neuropathic Pain
Peripheral Nervous System
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Neuralgia
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases