Diabetic Peripheral Neuropathic PainPhase 2NCT04146896

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

A Phase 2 study testing NYX-2925 50 mg in people with Diabetic Peripheral Neuropathic Pain, run by Aptinyx at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetic Peripheral Neuropathic Pain
What is being tested?: NYX-2925 50 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 228 participants
Where: 35 sitesUnited States
Study dates: 12 Nov 2019to 23 Feb 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Aptinyx Clinical Site
Blackfoot, Idaho, 83221
Aptinyx Clinical Site
Brandon, Florida, 33511
Aptinyx Clinical Site
Brooklyn, New York, 11235
Aptinyx Clinical Site
Clearwater, Florida, 33765
Aptinyx Clinical Site
Decatur, Georgia, 30030
Aptinyx Clinical Site
Duncansville, Pennsylvania, 16635
Aptinyx Clinical Site
Flossmoor, Illinois, 60422
Aptinyx Clinical Site
Fresno, California, 93720
Aptinyx Clinical Site
Greenacres City, Florida, 33467
Aptinyx Clinical Site
Greenville, North Carolina, 27834
Aptinyx Clinical Site
Hazelwood, Missouri, 63042
Aptinyx Clinical Site
Houston, Texas, 77030
Aptinyx Clinical Site
Irvine, California, 92612
Aptinyx Clinical Site
Las Vegas, Nevada, 89123
Aptinyx Clinical Site
Lomita, California, 90717
Aptinyx Clinical Site
Los Angeles, California, 90048
Aptinyx Clinical Site
Marietta, Georgia, 30060
Aptinyx Clinical Site
Mesquite, Texas, 75149
Aptinyx Clinical Site
Miami, Florida, 33126
Aptinyx Clinical Site
Miami, Florida, 33144
Aptinyx Clinical Site
New Port Richey, Florida, 34655
Aptinyx Clinical Site
New York, New York, 10036
Aptinyx Clinical Site
Norco, California, 92860
Aptinyx Clinical Site
Plano, Texas, 75024
Aptinyx Clinical Site
Pomona, California, 91767
Aptinyx Clinical Site
Rochester, Michigan, 48307
Aptinyx Clinical Site
Rochester, New York, 14618
Aptinyx Clinical Site
San Antonio, Texas, 78229
Aptinyx Clinical Site
Santa Ana, California, 92705
Aptinyx Clinical Site
Tampa, Florida, 33615
Aptinyx Clinical Site
Tampa, Florida, 33634
Aptinyx Clinical Site
Tustin, California, 92780
Aptinyx Clinical Site
Winston-Salem, North Carolina, 27103
Aptinyx Clinical Site
Winter Haven, Florida, 33880
Aptinyx Clinical Site
Winter Park, Florida, 32789

Other trials in United States

About this study

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

To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

Read the 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.

Conditions: Diabetic Peripheral Neuropathic Pain
Being tested: NYX-2925 50 mg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NYX-2925 50 mgDrug
NYX-2925 administered orally
PlaceboDrug
Placebo administered orally

Study groups in NCT04146896
Study group	Role	What they receive
NYX-2925	Experimental	NYX-2925 50 mg Receives: Drug: NYX-2925 50 mg
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Intensity Numeric Rating Scale (NRS) Score
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.
Measured: Week 12

Secondary outcomes (6)

Daily Sleep Interference Scale (DSIS) Score
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).
Measured: Week 12
Patient Global Impression of Change (PGI-C)
Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)
Measured: Week 12
Number of Subjects Achieving ≥30% Pain Reduction
Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Measured: Week 12
Number of Subjects Achieving ≥50% Reduction
Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Measured: Week 12
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score
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. Scores range from 0-126, and lower scores indicate improved quality of life.
Measured: Week 12
Use of Rescue Medication
Number of subjects using rescue medication
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201923 Feb 2022

First posted31 Oct 2019
Study start12 Nov 2019
Primary completion23 Feb 2022
Study completion23 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized to receive either placebo or NYX-2925.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04146896
Sponsor's protocol ID: NYX-2925-2008
Status last verified: Apr 2023
First submitted: 29 Oct 2019
Last updated: 28 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy

All Diabetic Peripheral Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04146896
Acronym / sponsor ID: NYX-2925-2008
Conditions: Diabetic Peripheral Neuropathic Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: AptinyxIndustry (pharma, biotech, devices)
Collaborators: Worldwide Clinical Trials
Study start: 12 Nov 2019 (actual)
Primary completion: 23 Feb 2022 (actual)
Study completion: 23 Feb 2022 (actual)
First posted: 31 Oct 2019 (actual)
Results: Posted 28 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Subjects will be randomized to receive either placebo or NYX-2925.

Arm	Type	Receives
NYX-2925	Experimental	Drug: NYX-2925 50 mgNYX-2925 50 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NYX-2925 50 mgNYX-2925 administered orally	Drug	NYX-2925
PlaceboPlacebo administered orally	Drug	Placebo

Primary outcome

Pain Intensity Numeric Rating Scale (NRS) Score
Time frame: 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.

6 secondary outcomes

Daily Sleep Interference Scale (DSIS) Score
Time frame: Week 12
Patient Global Impression of Change (PGI-C)
Time frame: Week 12
Number of Subjects Achieving ≥30% Pain Reduction
Time frame: Week 12
Number of Subjects Achieving ≥50% Reduction
Time frame: Week 12
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score
Time frame: Week 12
Use of Rescue Medication
Time frame: Week 12

Results and safety

Results posted to the registry on 28 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NYX-2925	114	97
Placebo	114	92

Primary outcome: Pain Intensity Numeric Rating Scale (NRS) Score

Time frame: Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	NYX-2925 n = 113	Placebo n = 112
Value	-2.01 (1.821)	-2.27 (2.102)

NYX-2925 vs Placebo: p = 0.704, t-test, 2 sided

Population analysed: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

6 secondary outcomes are reported in the full results.

Adverse events

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 12). The protocol required adverse events to be followed to resolution of the adverse event.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NYX-2925	1 of 114 (0.9%)	15 of 114 (13.2%)	0 of 114
Placebo	6 of 114 (5.3%)	15 of 114 (13.2%)	2 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetic Peripheral Neuropathic Pain

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NYX-2925 50 mg in people with Diabetic Peripheral Neuropathic Pain, run by Aptinyx at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Numeric Rating Scale (NRS) Score (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04146896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.