CompletedPhase 2

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

United States301 participantsStarted 2017-06-27

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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).
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Numeric Rating Scale (NRS) Average Pain Intensity

Timeframe: From baseline (average of -7 to -1) to Week 4 (average of Days 22 through 28)

Trial details

NCT IDNCT03219320

SponsorAptinyx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-02

Results submitted2020-05-15

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials