A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy

Inclusion Criteria: * Confirmed diagnosis of probable diabetic polyneuropathy, as defined by the Toronto consensus criteria and a TCNS \> 5 or abnormal DPNCheck or abnormal NCS. * Probable neuropathic pain as defined by the NeuPSIG guidelines. * Symmetric distal pain worse in the distal lower extremities present for \> 6 months. * Average pain score on a NRS of ≥ 4 during the baseline week. Exclusion Criteria: * Prior or current use of a CGRP mAbs or CGRP antagonists. * Opioid regimen other than stable low dose of Tramadol (maximum 200 mg/day). * The patient has a lifetime history of psychosis, bipolar mania, or dementia. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded. * Initiation of new neuropathic pain medications such as gabapentinoid medications (gabapentin, pregabalin) and/or capsaicin (Quetenza), botulinum toxin type A, serotonin/norepinephrine reuptake inhibitors (TCA or duloxetine or venlafaxine) 1 month prior to enrollment or for the duration of the randomized placebo-controlled phase of the study. Current and ongoing pain treatment will be allowed in stable dose (anticonvulsants, antidepressants, tramadol, topical treatments (excluding high dose capsaicin patch and botulinum toxin type A) (Paracetamol 1g and over-the-counter NSAIDS as needed up to four times daily are allowed as rescue medicine). * Suspected cause of lower extremit…