Last updated 21 days ago
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
450 patients around the world
Available in United States, Mexico
Eli Lilly and Company
4Research sites
450Patients around the world
This study is for people with
Neuropathic Pain
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Have a Visual Analog Scale (VAS) pain value ≥40 and <95 at screening.Presence of painful distal sensory polyneuropathy (DSP) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities.Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation.Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications.Individuals NOT of childbearing potential may participate in the trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- History of other potential causative and/or confounding sources of pain that may impair self-assessment of pain due to painful DSP.Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest.Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening and have a hemoglobin A1c (HbA1c) >11 at screening.Cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision, or cancer treatment which led to chemotherapy-induced peripheral neuropathy.Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.Have a surgery planned during the study for any reason.History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.
Sites
CICLO. Centro de Investigación Clínica de Oaxaca - Oaxaca
Centro de Investigación Clínica y Medicina Traslacional CIMeT
Medical Care & Research SA de CV
Grupo Médico Camino S.C. - México
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06568042
