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Trial record 2 of 5 for:    NYX-2925

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146896
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Aptinyx

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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.

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): NCT04146896


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

Locations
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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

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Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT04146896    
Other Study ID Numbers: NYX-2925-2008
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms