EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA

Egyéb feltételek

• 7.1 ISA-Specific Inclusion Criteria (To be used in conjunction with Platform Protocol criteria; note, some ISA criteria may be more stringent than Platform criteria; always follow the more stringent criteria when determining eligibility.)
• Provides written consent for the EN21-01 ISA. Legally Authorized Representatives (LARs) are not allowed, but impartial witnesses may be utilized as needed for visually impaired participants
• Patient-reported daily 11-point NRS (for average pain over the last 24 hours) meets the criteria specified in "Appendix B: Blinded Information" during both the 7-day screening and 7-day baseline periods. The algorithm will be assessed centrally; Waivers to the inclusion criteria will not be allowed. 7.2 ISA-Specific Exclusion Criteria (To be used in conjunction with Platform Protocol criteria; note, some ISA criteria may be more stringent than Platform criteria; always follow the more stringent criteria when determining eligibility.) Participants fulfilling any of the following criteria are not eligible for the study
• Diagnosis of alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 2 years before the Screening visit. **This criterion is more stringent than a related Platform Protocol criterion.**
• Moderate or severe renal impairment, known (documented) or defined as an estimated/calculated creatinine clearance/estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, according to the Chronic Kidney Disease Epidemiology Collaboration formula during the screening process. **This criterion is more stringent than a related Platform Protocol criterion.**
• Any of the following conditions related to corrected QT intervals using Fridericia's formula (QTcF):; A QTcF > 500 ms prior to starting IP, up to and including the V3 pre-dose ECG; A history of the following additional risk factors for torsade de pointes: heart failure, hypokalemia, history or family history of long QT syndrome
• History of myocardial infarction, other clinically active significant heart disease, or stroke. **This criterion is more stringent than a related Platform Protocol criterion.**
• Participants known to have participated in four or more studies for investigational pain drugs
• Participants known to be non-responders to more than three previous neuropathic pain medications at adequate doses over at least 4 weeks. Adequate doses (given as total daily doses) are defined as follows: 1,800 mg gabapentin; 300 mg pregabalin; opioid analgesics 60 mg oxycodone equivalent or 200 mg tramadol; 75 mg amitriptyline or equivalent tricyclic antidepressant; 60 mg duloxetine; 150 mg venlafaxine
• Known hypersensitivity or contraindication to any excipients of the study drug formulation
• Taking prohibited medications as described in Appendix A, "Prohibited Medications."
• Major depressive episode within the 6 months before screening and/or a history of diagnosed recurrent major depressive disorder within two years. Any of the following conditions related to suicidality:; Any suicidal ideation with intent, with or without a plan, at screening, i.e., answering "yes" to questions 4 or 5 on the Suicidal Ideation section of the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS); Answering "yes" on any item of the Suicidal Behavior Section (except for the "non-suicidal self-injurious behavior") of the C-SSRS if this behavior occurred in the past 2 years; A lifetime history of suicide attempt (V1)
• Previous known or possible exposure to NRD135S.E1; Waivers to the exclusion criteria will not be allowed