Trial Outcomes & Findings for Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (NCT NCT03219320)
NCT ID: NCT03219320
Last Updated: 2020-06-09
Results Overview
Change in the NRS score assessing average pain intensity in the past 24 hours; 0=no pain, 10=worst pain imaginable
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
301 participants
Primary outcome timeframe
From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)
Results posted on
2020-06-09
Participant Flow
Participant milestones
| Measure |
NYX-2925 200 mg Once Daily (QD)
NYX-2925 200 mg PO once daily (QD)
|
NYX-2925 50 mg QD
NYX-2925 50 mg PO QD
|
NYX-2925 10 mg QD
NYX-2925 10 mg PO QD
|
Placebo QD
Placebo PO QD
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
77
|
77
|
72
|
|
Overall Study
COMPLETED
|
73
|
74
|
72
|
69
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
NYX-2925 200 mg QD
n=75 Participants
NYX-2925 200 mg PO QD
|
NYX-2025 50 mg QD
n=77 Participants
NYX-2925 50 mg PO QD
|
NYX-2925 10 mg QD
n=77 Participants
NYX-2925 10 mg PO QD
|
Placebo QD
n=72 Participants
Placebo PO QD
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
59 Participants
n=483 Participants
|
233 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
68 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
137 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
164 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
114 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
186 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
70 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
215 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=93 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=27 Participants
|
NA Participants
n=483 Participants
|
NA Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=93 Participants
|
77 participants
n=4 Participants
|
77 participants
n=27 Participants
|
72 participants
n=483 Participants
|
301 participants
n=36 Participants
|
|
DPN Disease History (years)
|
3.97 years
STANDARD_DEVIATION 2.723 • n=93 Participants
|
3.46 years
STANDARD_DEVIATION 2.632 • n=4 Participants
|
3.88 years
STANDARD_DEVIATION 2.528 • n=27 Participants
|
3.91 years
STANDARD_DEVIATION 2.373 • n=483 Participants
|
3.8 years
STANDARD_DEVIATION 2.565 • n=36 Participants
|
PRIMARY outcome
Timeframe: From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)Population: 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. \[mixed effects repeated measures (MMRM)\]
Change in the NRS score assessing average pain intensity in the past 24 hours; 0=no pain, 10=worst pain imaginable
Outcome measures
| Measure |
NYX-2925 10 mg QD
n=77 Participants
NYX-2925 10 mg PO QD
|
Placebo QD
n=72 Participants
Placebo PO QD
|
NYX-2925 200 mg QD
n=74 Participants
NYX-2925 200 mg PO QD
|
NYX-2025 50 mg QD
n=77 Participants
NYX-2925 50 mg PO QD
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) Average Pain Intensity
|
-1.15 score on a scale
Standard Error 0.19
|
-1.23 score on a scale
Standard Error 0.19
|
-1.50 score on a scale
Standard Error 0.19
|
-1.61 score on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: baseline to week 4Population: 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. \[mixed effects repeated measures (MMRM)\]
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
Outcome measures
| Measure |
NYX-2925 10 mg QD
n=35 Participants
NYX-2925 10 mg PO QD
|
Placebo QD
n=35 Participants
Placebo PO QD
|
NYX-2925 200 mg QD
n=37 Participants
NYX-2925 200 mg PO QD
|
NYX-2025 50 mg QD
n=41 Participants
NYX-2925 50 mg PO QD
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline
|
-1.42 score on a scale
Standard Error 0.29
|
-1.03 score on a scale
Standard Error 0.29
|
-1.55 score on a scale
Standard Error 0.28
|
-1.62 score on a scale
Standard Error 0.26
|
POST_HOC outcome
Timeframe: baseline to week 4Population: 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. \[mixed effects repeated measures (MMRM)\]
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
Outcome measures
| Measure |
NYX-2925 10 mg QD
n=32 Participants
NYX-2925 10 mg PO QD
|
Placebo QD
n=33 Participants
Placebo PO QD
|
NYX-2925 200 mg QD
n=36 Participants
NYX-2925 200 mg PO QD
|
NYX-2025 50 mg QD
n=26 Participants
NYX-2925 50 mg PO QD
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) Average Pain Intensity in Subjects With DPN >= 4 Years
|
-1.00 score on a scale
Standard Error 0.29
|
-0.72 score on a scale
Standard Error 0.27
|
-1.19 score on a scale
Standard Error 0.27
|
-1.93 score on a scale
Standard Error 0.31
|
Adverse Events
NYX-2925 200 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
NYX-2925 50 mg QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NYX-2925 10 mg QD
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo QD
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NYX-2925 200 mg QD
n=75 participants at risk
NYX-2925 200 mg PO QD
|
NYX-2925 50 mg QD
n=77 participants at risk
NYX-2925 50 mg PO QD
|
NYX-2925 10 mg QD
n=77 participants at risk
NYX-2925 10 mg PO QD
|
Placebo QD
n=72 participants at risk
Placebo PO QD
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.00%
0/75 • 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.
|
0.00%
0/77 • 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.
|
0.00%
0/77 • 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.
|
1.4%
1/72 • Number of events 2 • 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.
|
Other adverse events
| Measure |
NYX-2925 200 mg QD
n=75 participants at risk
NYX-2925 200 mg PO QD
|
NYX-2925 50 mg QD
n=77 participants at risk
NYX-2925 50 mg PO QD
|
NYX-2925 10 mg QD
n=77 participants at risk
NYX-2925 10 mg PO QD
|
Placebo QD
n=72 participants at risk
Placebo PO QD
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/75 • 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.
|
0.00%
0/77 • 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.
|
5.2%
4/77 • 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.
|
0.00%
0/72 • 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.
|
|
Nervous system disorders
Headache
|
1.3%
1/75 • 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.
|
1.3%
1/77 • 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.
|
5.2%
4/77 • 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.
|
4.2%
3/72 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/75 • 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.
|
3.9%
3/77 • 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.
|
1.3%
1/77 • 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.
|
1.4%
1/72 • 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.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/75 • 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.
|
0.00%
0/77 • 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.
|
2.6%
2/77 • 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.
|
0.00%
0/72 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/75 • 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.
|
0.00%
0/77 • 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.
|
2.6%
2/77 • 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.
|
0.00%
0/72 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place