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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Diabetic Peripheral Neuropathy
Interventions Drug: NYX-2925
Drug: Placebo
Enrollment 301
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NYX-2925 200 mg Once Daily (QD) NYX-2925 50 mg QD NYX-2925 10 mg QD Placebo QD
Hide Arm/Group Description NYX-2925 200 mg PO once daily (QD) NYX-2925 50 mg PO QD NYX-2925 10 mg PO QD Placebo PO QD
Period Title: Overall Study
Started 75 77 77 72
Completed 73 74 72 69
Not Completed 2 3 5 3
Arm/Group Title NYX-2925 200 mg QD NYX-2025 50 mg QD NYX-2925 10 mg QD Placebo QD Total
Hide Arm/Group Description NYX-2925 200 mg PO QD NYX-2925 50 mg PO QD NYX-2925 10 mg PO QD Placebo PO QD Total of all reporting groups
Overall Number of Baseline Participants 75 77 77 72 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 77 participants 77 participants 72 participants 301 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
57
  76.0%
57
  74.0%
60
  77.9%
59
  81.9%
233
  77.4%
>=65 years
18
  24.0%
20
  26.0%
17
  22.1%
13
  18.1%
68
  22.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 77 participants 77 participants 72 participants 301 participants
Female
31
  41.3%
37
  48.1%
32
  41.6%
37
  51.4%
137
  45.5%
Male
44
  58.7%
40
  51.9%
45
  58.4%
35
  48.6%
164
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 77 participants 77 participants 72 participants 301 participants
Hispanic or Latino
30
  40.0%
29
  37.7%
27
  35.1%
28
  38.9%
114
  37.9%
Not Hispanic or Latino
45
  60.0%
47
  61.0%
50
  64.9%
44
  61.1%
186
  61.8%
Unknown or Not Reported
0
   0.0%
1
   1.3%
0
   0.0%
0
   0.0%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 77 participants 77 participants 72 participants 301 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   2.6%
0
   0.0%
2
   0.7%
Asian
2
   2.7%
2
   2.6%
2
   2.6%
4
   5.6%
10
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.3%
0
   0.0%
1
   1.4%
2
   0.7%
Black or African American
17
  22.7%
20
  26.0%
18
  23.4%
15
  20.8%
70
  23.3%
White
55
  73.3%
53
  68.8%
55
  71.4%
52
  72.2%
215
  71.4%
More than one race NA [1]  NA [1]  NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
1
   1.3%
1
   1.3%
0
   0.0%
0
   0.0%
2
   0.7%
[1]
not collected
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 77 participants 77 participants 72 participants 301 participants
75 77 77 72 301
DPN Disease History (years)   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 77 participants 77 participants 72 participants 301 participants
3.97  (2.723) 3.46  (2.632) 3.88  (2.528) 3.91  (2.373) 3.8  (2.565)
[1]
Measure Description: Number of years subject experienced DPN - Lower Extremities
1.Primary Outcome
Title Numeric Rating Scale (NRS) Average Pain Intensity
Hide Description Change in the NRS score assessing average pain intensity in the past 24 hours; 0=no pain, 10=worst pain imaginable
Time Frame From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were included in the safety population, were randomized, and had at least 4 post-baseline daily average pain scores are included in the efficacy population. [mixed effects repeated measures (MMRM)]
Arm/Group Title NYX-2925 200 mg QD NYX-2025 50 mg QD NYX-2925 10 mg QD Placebo QD
Hide Arm/Group Description:
NYX-2925 200 mg PO QD
NYX-2925 50 mg PO QD
NYX-2925 10 mg PO QD
Placebo PO QD
Overall Number of Participants Analyzed 74 77 77 72
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.50  (0.19) -1.61  (0.19) -1.15  (0.19) -1.23  (0.19)
2.Secondary Outcome
Title Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline
Hide Description 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
Time Frame baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were included in the safety population, were randomized, and had at least 4 post-baseline daily average pain scores are included in the efficacy population. [mixed effects repeated measures (MMRM)]
Arm/Group Title NYX-2925 200 mg QD NYX-2025 50 mg QD NYX-2925 10 mg QD Placebo QD
Hide Arm/Group Description:
NYX-2925 200 mg PO QD
NYX-2925 50 mg PO QD
NYX-2925 10 mg PO QD
Placebo PO QD
Overall Number of Participants Analyzed 37 41 35 35
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.55  (0.28) -1.62  (0.26) -1.42  (0.29) -1.03  (0.29)
3.Post-Hoc Outcome
Title Numeric Rating Scale (NRS) Average Pain Intensity in Subjects With DPN >= 4 Years
Hide Description Change in the NRS score assessing average pain intensity in the past 24 hours in patients with DPN >=4 years; 0=no pain, 10=worst pain imaginable
Time Frame baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were included in the safety population, were randomized, and had at least 4 post-baseline daily average pain scores are included in the efficacy population. [mixed effects repeated measures (MMRM)]
Arm/Group Title NYX-2925 200 mg QD NYX-2025 50 mg QD NYX-2925 10 mg QD Placebo QD
Hide Arm/Group Description:
NYX-2925 200 mg PO QD
NYX-2925 50 mg PO QD
NYX-2925 10 mg PO QD
Placebo PO QD
Overall Number of Participants Analyzed 36 26 32 33
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.19  (0.27) -1.93  (0.31) -1.00  (0.29) -0.72  (0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NYX-2025 50 mg QD, Placebo QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 4). The protocol required adverse events to be followed to resolution of the adverse event.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NYX-2925 200 mg QD NYX-2925 50 mg QD NYX-2925 10 mg QD Placebo QD
Hide Arm/Group Description NYX-2925 200 mg PO QD NYX-2925 50 mg PO QD NYX-2925 10 mg PO QD Placebo PO QD
All-Cause Mortality
NYX-2925 200 mg QD NYX-2925 50 mg QD NYX-2925 10 mg QD Placebo QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)      0/77 (0.00%)      0/77 (0.00%)      0/72 (0.00%)    
Hide Serious Adverse Events
NYX-2925 200 mg QD NYX-2925 50 mg QD NYX-2925 10 mg QD Placebo QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/75 (0.00%)      0/77 (0.00%)      0/77 (0.00%)      1/72 (1.39%)    
Hepatobiliary disorders         
Hepatobiliary disorders  1 [1]  0/75 (0.00%)  0/77 (0.00%)  0/77 (0.00%)  1/72 (1.39%)  2
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
[1]
Cholecystitis, Gallbladder perforation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
NYX-2925 200 mg QD NYX-2925 50 mg QD NYX-2925 10 mg QD Placebo QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/75 (4.00%)      4/77 (5.19%)      12/77 (15.58%)      4/72 (5.56%)    
Gastrointestinal disorders         
Diarrhoea  1  1/75 (1.33%)  3/77 (3.90%)  1/77 (1.30%)  1/72 (1.39%) 
Infections and infestations         
Upper respiratory tract infection  1  0/75 (0.00%)  0/77 (0.00%)  4/77 (5.19%)  0/72 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  1/75 (1.33%)  0/77 (0.00%)  2/77 (2.60%)  0/72 (0.00%) 
Musculoskeletal and connective tissue disorders         
arthralgia  1  0/75 (0.00%)  0/77 (0.00%)  2/77 (2.60%)  0/72 (0.00%) 
Nervous system disorders         
Headache  1  1/75 (1.33%)  1/77 (1.30%)  4/77 (5.19%)  3/72 (4.17%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aptinyx Clinical Development
Organization: Aptinyx
Phone: 847-871-0377 ext 1
EMail: clinicalstudies@aptinyx.com
Layout table for additonal information
Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT03219320    
Other Study ID Numbers: NYX-2925-2001
First Submitted: July 13, 2017
First Posted: July 17, 2017
Results First Submitted: May 15, 2020
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020