Distal Sensory Polyneuropathy, Neuropathic Pain
Conditions
Keywords
Peripheral Neuropathy, Diabetic Peripheral Neuropathy, Chemotherapy Induced Peripheral Neuropathy, HIV Induced Peripheral Neuropathy
Brief summary
The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee. Participation may last up to 30 weeks including screening.
Interventions
DRUGLY3848575
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 (with or without involvement of the hands). * 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.
Exclusion criteria
* Other etiologies of pain that may not be due to DSP or confound the assessment 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, have a healthcare provider who manages the participants' diabetes, 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 that caused distal sensory polyneuropathy. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) | Baseline, Week 12 |
| Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1 | Baseline, Week 12 |
| Mean Change from Baseline in Pain Interference with Sleep | Baseline, Week 12 |
| Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a) | Baseline, Week 12 |
| Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b) | Baseline, Week 12 |
| Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2) | Baseline, Week 12 |
| Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity | Baseline, Week 12 |
| Mean Overall Improvement as Measured by Patient's Global Impression of Change | Week 12 |
| Use of Rescue Medication | Baseline up to Week 12 |
| Pharmacokinetic (PK): Serum Concentration of LY3848575 | Baseline up to Week 12 |
Countries
Canada, Germany, Japan, Mexico, Poland, South Korea, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed