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

Sponsor

Aptinyx (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04146896

Collaborator

Worldwide Clinical Trials (Other)

229

Enrollment

Locations

Arms

30.6

Anticipated Duration (Months)

6.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 a 13- to 16-week study, including a 1- to 4-week Screening Period, followed by a 12- week double-blind, randomized, placebo-controlled Treatment Period.

Study Design

Study Type:

Interventional

Actual Enrollment :

229 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomized to receive either placebo or NYX-2925.Subjects will be randomized to receive either placebo or NYX-2925.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Randomization algorithm, randomization allocation, allocation to study drug or placebo.

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 :

Nov 12, 2019

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NYX-2925 NYX-2925 50 mg	Drug: NYX-2925 50 mg NYX-2925 administered orally
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo administered orally

Arm

Intervention/Treatment

Experimental: NYX-2925

NYX-2925 50 mg

Drug: NYX-2925 50 mg

NYX-2925 administered orally

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Placebo administered orally

Outcome Measures

Primary Outcome Measures

Numeric Rating Scale (NRS) score [Week 12]
Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.

Secondary Outcome Measures

Daily Sleep Interference Scale (DSIS) score [Week 12]
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores. The DSIS asks participants to ''Select the number that best describes how much your pain has interfered with your sleep during the past 24 hours.'' Response options for the DSIS range from 0 (did not interfere with sleep) to 10 (completely interfered with sleep/unable to sleep due to pain).
Patient Global Impression of Change (PGI-C) [Week 12]
Percentage of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)
Percentage of subjects achieving ≥30% pain reduction [Week 12]
Percentage of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Percentage of subjects achieving ≥50% reduction [Week 12]
Percentage of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score [Week 12]
Change from baseline in the Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score. The QOL-DN is a 47 item subject reported questionnaire, in which lower scores indicate improved quality of life.
Use of rescue medication [Week 12]
Use of rescue medication, including the proportion of subjects using rescue medication, the frequency and amount used
Cumulative response (percent reduction from baseline) [Week 12]
Cumulative response (percent reduction from baseline) in the weekly mean NRS average pain intensity at Week 12
Change from baseline in mean NRS at each week [Week 1 - Week 12]
Change from baseline in the weekly mean of the daily Numerical Rating Scale (NRS) at each week from Week 1 through Week 12

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Informed consent
Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities for ≥4 years and reports at least moderate pain over the last week
Stable diabetic and protocol allowed medication during the study
Agrees to use highly effective birth control during the study
Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
Current or historical serious medical conditions
Prior participation in NYX-2925 clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aptinyx Clinical Site	Fresno	California	United States	93720
2	Aptinyx Clinical Site	Irvine	California	United States	92612
3	Aptinyx Clinical Site	Lomita	California	United States	90717
4	Aptinyx Clinical Site	Los Angeles	California	United States	90048
5	Aptinyx Clinical Site	Norco	California	United States	92860
6	Aptinyx Clinical Site	Pomona	California	United States	91767
7	Aptinyx Clinical Site	Santa Ana	California	United States	92705
8	Aptinyx Clinical Site	Tustin	California	United States	92780
9	Aptinyx Clinical Site	Brandon	Florida	United States	33511
10	Aptinyx Clinical Site	Clearwater	Florida	United States	33765
11	Aptinyx Clinical Site	Greenacres City	Florida	United States	33467
12	Aptinyx Clinical Site	Miami	Florida	United States	33126
13	Aptinyx Clinical Site	Miami	Florida	United States	33144
14	Aptinyx Clinical Site	New Port Richey	Florida	United States	34655
15	Aptinyx Clinical Site	Tampa	Florida	United States	33615
16	Aptinyx Clinical Site	Tampa	Florida	United States	33634
17	Aptinyx Clinical Site	Winter Haven	Florida	United States	33880
18	Aptinyx Clinical Site	Winter Park	Florida	United States	32789
19	Aptinyx Clinical Site	Decatur	Georgia	United States	30030
20	Aptinyx Clinical Site	Marietta	Georgia	United States	30060
21	Aptinyx Clinical Site	Blackfoot	Idaho	United States	83221
22	Aptinyx Clinical Site	Flossmoor	Illinois	United States	60422
23	Aptinyx Clinical Site	Rochester	Michigan	United States	48307
24	Aptinyx Clinical Site	Hazelwood	Missouri	United States	63042
25	Aptinyx Clinical Site	Las Vegas	Nevada	United States	89123
26	Aptinyx Clinical Site	Brooklyn	New York	United States	11235
27	Aptinyx Clinical Site	New York	New York	United States	10036
28	Aptinyx Clinical Site	Rochester	New York	United States	14618
29	Aptinyx Clinical Site	Greenville	North Carolina	United States	27834
30	Aptinyx Clinical Site	Winston-Salem	North Carolina	United States	27103
31	Aptinyx Clinical Site	Duncansville	Pennsylvania	United States	16635
32	Aptinyx Clinical Site	Houston	Texas	United States	77030
33	Aptinyx Clinical Site	Mesquite	Texas	United States	75149
34	Aptinyx Clinical Site	Plano	Texas	United States	75024
35	Aptinyx Clinical Site	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Aptinyx
Worldwide Clinical Trials

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aptinyx

ClinicalTrials.gov Identifier:

NCT04146896

Other Study ID Numbers:

NYX-2925-2008

First Posted:

Oct 31, 2019

Last Update Posted:

Oct 28, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuralgia

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Oct 28, 2021