Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Peripheral Neuropathic Pain; Diabetic Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: ETX-018810; Placebo
Intervention description: Study Drug; Matching Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-Controlled, Parallel-Group
Masking: Double (Participant, Investigator)
Masking description: Double-Blind
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate
      the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is ≥18 and ≤75 years of age at the time of signing ICF.

          -  The subject has a diagnosis of type 1 or 2 diabetes mellitus.

          -  The subject has diabetic neuropathy of a symmetrical nature in the lower extremities
             for ≥6 months to ≤10 years

          -  The subject reports at least moderate pain intensity

          -  The subject's onset of neuropathic pain is at least 3 months before the screening
             visit.

          -  The subject has used a stable regimen of antidiabetic agents for at least 1 month
             before the baseline visit or has achieved adequate glycemic control through diet and
             exercise.

          -  The subject has clinical laboratory values within normal limits or abnormal values
             that the investigator deems not clinically significant.

          -  Sexually active male subjects with female partners of childbearing potential and
             sexually active female subjects of childbearing potential must agree to practice
             effective contraception or to remain abstinent during the study and for 4 weeks after
             the last dose of investigational product

          -  The subject is capable of giving signed informed consent and agrees to provide
             authorization for use and release of health records.

        Exclusion Criteria:

          -  The subject has pain that cannot be clearly differentiated from or that could
             interfere with the assessment of DPNP.

          -  The subject has neurologic and/or circulatory disorders that are unrelated to diabetic
             neuropathy

          -  The subject has a history of hypoglycemia that disturbed consciousness or ketoacidosis
             that required hospitalization within the 3 months before screening.

          -  The subject has clinically significant and/or unstable renal, hepatic, hematologic,
             immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that
             would compromise participation in the study in the judgment of the investigator.

          -  The subject has any neurological disease that could interfere with participation in
             the study (eg, Huntington's disease, Parkinson's disease, Alzheimer's disease,
             multiple sclerosis, seizures, epilepsy, stroke).

          -  The subject has an amputation of a lower extremity. Toe amputation is allowed.

          -  The subject has clinically significant abnormal electrocardiogram (ECG) findings at
             screening or baseline.

          -  The subject is likely to require major surgery during the study.

          -  The subject is pregnant or lactating.

          -  The subject is unwilling or unable to discontinue current medications for neuropathic
             pain, including topical agents.

          -  The subject is unable to refrain from using nonsteroidal anti-inflammatory drugs
             (NSAIDs); antiepileptic drugs, steroids, cannabinoids, or major opioids, muscle
             relaxants, tramadol, or tapentadol throughout the study.

          -  The subject has used prohibited nonpharmacologic therapies, including acupuncture,
             transcutaneous electrical nerve stimulation, etc, within 30 days before baseline/Day 1
             or anticipates use of such therapies during the study.