Diabetic Peripheral NeuropathyPhase 2DPNNCT03219320

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

A Phase 2 study testing NYX-2925 in people with Diabetic Peripheral Neuropathy, 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 multiple dose levels 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 Neuropathy
What is being tested?: NYX-2925
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 301 participants
Where: 35 sitesUnited States
Study dates: 27 Jun 2017to 2 Nov 2018
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

An Institutional Review Board-approved written informed consent and privacy language (Health Insurance Portability and Accountability Act) authorization must be obtained from the subject prior to performing any study-related procedures.
Subjects who consent to being included in a subject registry database.
Male and female subjects ≥18 and ≤75 years of age.
Subjects with a diagnosis of Type 2 diabetes.
Subjects with a score of ≥4 and ≤9 on the 11-point numeric rating scale (NRS) for average pain intensity over the past 24 hours at Visit 1.
Hemoglobin A1c (HbA1c) ≤11% (measured at Visit 1).

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Stable use of diabetic medications beginning 1 month prior to Visit 1 (Adequate glycemic control with only diet and exercise is also permitted.).
Subjects with diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months to ≤10 years, and diagnosed by a score of ≥3 on Michigan Neuropathy Screening Instrument.
Body mass index of <40 kg/m^2
Calculated creatinine clearance of ≥60 mL/minute (Cockcroft-Gault formula).
Clinical laboratory values must be within normal limits or deemed not clinically significant by the investigator and sponsor-designated medical monitor.
Inclusion Criteria: Randomization Daily pain scores and diary compliance will be transferred into the interactive response technology system, which will assess the criteria for randomization. Subjects whose mean of the daily average pain intensity score during the preceding 7 (±1) days is within the protocol-defined algorithm and with adequate compliance with daily diary completion will be eligible for randomization.
Waivers to the inclusion criteria will NOT be allowed.

Who cannot join

Subjects who have a current diagnosis of major psychiatric disorder (including schizophrenia, bipolar disorder, or panic disorder), including those who have required an antipsychotic or mood stabilizer (e.g., lithium, carbamazepine, valproate) for a psychiatric condition in the past year, or subjects who have had a major depressive episode (MDE) in the past 6 months. Subjects with major depressive disorder (MDD) or generalized anxiety disorder (GAD) who have been on stable medications for the past 3 months (and are expected to remain stable for the duration of the trial) and whose condition is currently well-controlled may be included.
Subjects who have pain that cannot be clearly differentiated from, or could interfere with the assessment of peripheral diabetic neuropathy, as measured by the Masquerading Disorders Tool at Visit 1.
Neurologic disorders unrelated to diabetic neuropathy (e.g., phantom limb from amputation), skin condition in the area of neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis) that, in the judgment of the investigators, could interfere with reporting of pain due to diabetic neuropathy.
History of hypoglycemia that disturbed consciousness, or ketoacidosis requiring hospitalization within past 3 months.
Subjects with history of severe renal impairment.
Impaired hepatic function.

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Known history of significant cardiovascular condition.
History of Huntington's disease, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, or a history of seizures, epilepsy, or strokes.
HIV infection, hepatitis, or other ongoing infectious disease that the investigator considers clinically significant.
Concomitant use of antiepileptic drugs, non-steroidal anti-inflammatory drugs (except cardiac preventive acetylsalicylic acid), opioids, muscle relaxants, dextromethorphan (except low dose intermittent use for cough), tramadol, topical lidocaine, topical capsaicin, and selective norepinephrine reuptake inhibitors. Subjects are allowed to enter with a maximum of 1 allowed analgesic medication for neuropathic pain that has been taken at stable dose for at least 1 month (30 days) prior to Visit 1. Allowed analgesics may not be N-methyl-D-aspartate receptor ligands, must be non-opioid and non-sedative and must not interfere with subjects' pain reporting. Tricyclic antidepressants may be continued if designated as the single analgesic medication for the treatment of pain.
Sensitivity to, allergy to, or concomitant use of N-methyl-D-aspartate receptor ligands including ketamine, amantadine, dextromethorphan (except low dose intermittent use for cough), memantine, methadone, dextropropoxyphene, and/or ketobemidone.
Amputations of lower extremities (toe amputation is allowed).
Any condition, including serious medical conditions that could interfere with the ability of the subject to participate in the study or could confound study assessments.
Subjects who meet the criteria for suicidal intent, plan and/or behavior by scoring 3 or 4 on Questions 2 or 13, or 2 or higher on any Questions 1a (only if 1b is coded YES), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 14 based on the Sheehan - Suicidality Tracking Scale at Visit 1 or Visit 2.
Waivers to the exclusion criteria will NOT be allowed.

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Aptinyx Clinical Site
Anaheim, California, 92801
Aptinyx Clinical Site
Austin, Texas, 78731
Aptinyx Clinical Site
Berlin, New Jersey, 08009
Aptinyx Clinical Site
Bradenton, Florida, 34201
Aptinyx Clinical Site
Brandon, Florida, 33511
Aptinyx Clinical Site
Columbus, Georgia, 31904
Aptinyx Clinical Site
Dayton, Ohio, 45439
Aptinyx Clinical Site
Decatur, Georgia, 30033
Aptinyx Clinical Site
Flossmoor, Illinois, 60422
Aptinyx Clinical Site
Fort Myers, Florida, 33912
Aptinyx Clinical Site
Fresno, California, 93710
Aptinyx Clinical Site
Hallandale, Florida, 33009
Aptinyx Clinical Site
Hazelwood, Missouri, 63042
Aptinyx Clinical Site
Houston, Texas, 77058
Aptinyx Clinical Site
Jupiter, Florida, 33458
Aptinyx Clinical Site
Knoxville, Tennessee, 37909
Aptinyx Clinical Site
Memphis, Tennessee, 38119
Aptinyx Clinical Site
Meridian, Idaho, 83642
Aptinyx Clinical Site
Miami, Florida, 33012
Aptinyx Clinical Site
Miami, Florida, 33126
Aptinyx Clinical Site
Miami, Florida, 33175
Aptinyx Clinical Site
New London, Connecticut, 06320
Aptinyx Clinical Site
Norco, California, 92860
Aptinyx Clinical Site
Norfolk, Virginia, 23510
Aptinyx Clinical Site
Ocoee, Florida, 34761
Aptinyx Clinical Site
Orlando, Florida, 32801
Aptinyx Clinical Site
Orlando, Florida, 32806
Aptinyx Clinical Site
Phoenix, Arizona, 85053
Aptinyx Clinical Site
Plano, Texas, 75024
Aptinyx Clinical Site
Rochester, New York, 14618
Aptinyx Clinical Site
Santa Monica, California, 90404
Aptinyx Clinical Site
Tampa, Florida, 33603
Aptinyx Clinical Site
Tullahoma, Tennessee, 37388
Aptinyx Clinical Site
Tustin, California, 92480
Aptinyx Clinical Site
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose 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 multiple dose levels 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, parallel-group, placebo-controlled, multiple-dose 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 6 to 9-week study, including a 1 to 4-week (dependent on duration of washout period) Screening Period, followed by a 4-week double-blind, randomized, placebo-controlled Treatment Period, and a 1-week Follow Up Period. Subjects eligible for the study will randomize to receive either NYX-2925 or placebo for 4 weeks.

Conditions: Diabetic Peripheral Neuropathy
Being tested: NYX-2925, Placebo
Keywords: Type 2 Diabetes, Neuropathic Pain, Peripheral Nervous System
Medical subject headings: Diabetes Mellitus, Type 2, Neuralgia

What participants receive

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

NYX-2925Drug
NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
PlaceboDrug
Matching Placebo capsules.

Study groups in NCT03219320
Study group	Role	What they receive
Placebo Oral Capsule	Placebo comparator	Up to 300 subjects: Placebo Receives: Drug: Placebo
NYX-2925	Experimental	Up to 300 subjects: Multiple dose levels of NYX-2925 daily for 28 days Receives: Drug: NYX-2925

What is being measured

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

Numeric Rating Scale (NRS) Average Pain Intensity
Change in the NRS score assessing average pain intensity in the past 24 hours; 0=no pain, 10=worst pain imaginable
Measured: From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)

Secondary outcomes (1)

Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline
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
Measured: baseline to week 4

Timeline

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

27 Jun 20172 Nov 2018

First posted17 Jul 2017
Study start27 Jun 2017
Primary completion2 Nov 2018
Study completion2 Nov 2018

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 NeuropathyStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized to receive placebo or NYX-2925.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03219320
Sponsor's protocol ID: NYX-2925-2001
Acronym: DPN
Status last verified: Jun 2020
First submitted: 13 Jul 2017
Last updated: 9 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

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

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All Diabetic Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT03219320
Acronym / sponsor ID: DPN / NYX-2925-2001
Conditions: Diabetic Peripheral Neuropathy
Keywords: Type 2 Diabetes, Neuropathic Pain, Peripheral Nervous System
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: AptinyxIndustry (pharma, biotech, devices)
Collaborators: Syneos Health
Study start: 27 Jun 2017 (actual)
Primary completion: 2 Nov 2018 (actual)
Study completion: 2 Nov 2018 (actual)
First posted: 17 Jul 2017 (actual)
Results: Posted 9 Jun 2020

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 multiple dose levels of NYX-2925 versus placebo in treating the neuropathic pain associated with Diabetic Peripheral Neuropathy.

Detailed description

Study design

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

Arm	Type	Receives
Placebo Oral Capsule	Placebo comparator	Drug: PlaceboUp to 300 subjects: Placebo
NYX-2925	Experimental	Drug: NYX-2925Up to 300 subjects: Multiple dose levels of NYX-2925 daily for 28 days

Who may qualify

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

Key inclusion criteria (13 listed)

An Institutional Review Board-approved written informed consent and privacy language (Health Insurance Portability and Accountability Act) authorization must be obtained from the subject prior to performing any study-related procedures.
Subjects who consent to being included in a subject registry database.
Male and female subjects ≥18 and ≤75 years of age.
Subjects with a diagnosis of Type 2 diabetes.
Subjects with a score of ≥4 and ≤9 on the 11-point numeric rating scale (NRS) for average pain intensity over the past 24 hours at Visit 1.

Key exclusion criteria (15 listed)

Subjects who have a current diagnosis of major psychiatric disorder (including schizophrenia, bipolar disorder, or panic disorder), including those who have required an antipsychotic or mood stabilizer (e.g., lithium, carbamazepine, valproate) for a psychiatric condition in the past year, or subjects who have had a major depressive episode (MDE) in the past 6 months. Subjects with major depressive disorder (MDD) or generalized anxiety disorder (GAD) who have been on stable medications for the past 3 months (and are expected to remain stable for the duration of the trial) and whose condition is currently well-controlled may be included.
Subjects who have pain that cannot be clearly differentiated from, or could interfere with the assessment of peripheral diabetic neuropathy, as measured by the Masquerading Disorders Tool at Visit 1.
Neurologic disorders unrelated to diabetic neuropathy (e.g., phantom limb from amputation), skin condition in the area of neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis) that, in the judgment of the investigators, could interfere with reporting of pain due to diabetic neuropathy.
History of hypoglycemia that disturbed consciousness, or ketoacidosis requiring hospitalization within past 3 months.
Subjects with history of severe renal impairment.

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-2925NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	Drug	NYX-2925
PlaceboMatching Placebo capsules.	Drug	Placebo Oral Capsule

Primary outcome

Numeric Rating Scale (NRS) Average Pain Intensity
Time frame: From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)
Change in the NRS score assessing average pain intensity in the past 24 hours; 0=no pain, 10=worst pain imaginable

1 secondary outcome

Numeric Rating Scale (NRS) Average Pain Intensity in Patients Who Did Not Use a Concomitant Medication at Baseline
Time frame: baseline to week 4

Results and safety

Results posted to the registry on 9 Jun 2020, 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 200 mg Once Daily (QD)	75	73
NYX-2925 50 mg QD	77	74
NYX-2925 10 mg QD	77	72
Placebo QD	72	69

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

Time frame: From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28). Least squares mean (Standard Error). Unit: score on a scale

Measure	NYX-2925 200 mg QD n = 74	NYX-2025 50 mg QD n = 77	NYX-2925 10 mg QD n = 77	Placebo QD n = 72
Value	-1.50 (0.19)	-1.61 (0.19)	-1.15 (0.19)	-1.23 (0.19)

Population analysed: 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. \[mixed effects repeated measures (MMRM)\]

1 secondary outcome is 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 4). 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 200 mg QD	0 of 75 (0%)	3 of 75 (4%)	0 of 75
NYX-2925 50 mg QD	0 of 77 (0%)	4 of 77 (5.2%)	0 of 77
NYX-2925 10 mg QD	0 of 77 (0%)	12 of 77 (15.6%)	0 of 77
Placebo QD	1 of 72 (1.4%)	4 of 72 (5.6%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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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 in people with Diabetic Peripheral Neuropathy, 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 13 inclusion and 15 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 9 Jun 2020. 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 9 Jun 2020). 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?

Numeric Rating Scale (NRS) Average Pain Intensity (time frame: From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)). 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 NCT03219320.

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 9 Jun 2020.