Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
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ClinicalTrials.gov Identifier: NCT03219320 |
Recruitment Status :
Completed
First Posted : July 17, 2017
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
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Sponsor:
Aptinyx
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Aptinyx
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | NYX-2925 200 mg QD | NYX-2025 50 mg QD | NYX-2925 10 mg QD | Placebo QD | Total | |
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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 | |
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[Not Specified]
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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%
|
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>=65 years |
18 24.0%
|
20 26.0%
|
17 22.1%
|
13 18.1%
|
68 22.6%
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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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%
|
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Male |
44 58.7%
|
40 51.9%
|
45 58.4%
|
35 48.6%
|
164 54.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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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%
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Not Hispanic or Latino |
45 60.0%
|
47 61.0%
|
50 64.9%
|
44 61.1%
|
186 61.8%
|
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Unknown or Not Reported |
0 0.0%
|
1 1.3%
|
0 0.0%
|
0 0.0%
|
1 0.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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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%
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0 0.0%
|
2 0.7%
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|
Asian |
2 2.7%
|
2 2.6%
|
2 2.6%
|
4 5.6%
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10 3.3%
|
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Native Hawaiian or Other Pacific Islander |
0 0.0%
|
1 1.3%
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0 0.0%
|
1 1.4%
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2 0.7%
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Black or African American |
17 22.7%
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20 26.0%
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18 23.4%
|
15 20.8%
|
70 23.3%
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White |
55 73.3%
|
53 68.8%
|
55 71.4%
|
52 72.2%
|
215 71.4%
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More than one race | NA [1] | NA [1] | NA [1] | NA [1] | NA [2] | |
Unknown or Not Reported |
1 1.3%
|
1 1.3%
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0 0.0%
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0 0.0%
|
2 0.7%
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|
[1]
not collected
[2]
Total not calculated because data are not available (NA) in one or more arms.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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 |
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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
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Aptinyx Clinical Development |
Organization: | Aptinyx |
Phone: | 847-871-0377 ext 1 |
EMail: | clinicalstudies@aptinyx.com |
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 |