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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
Time frame: Baseline, Week 12
Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
Time frame: Baseline, Week 12
Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1
Time frame: Baseline, Week 12
Mean Change from Baseline in Pain Interference with Sleep
Time frame: Baseline, Week 12
Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a)
Time frame: Baseline, Week 12
Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b)
Time frame: Baseline, Week 12
Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2)
Time frame: Baseline, Week 12
Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity
Time frame: Baseline, Week 12
Mean Overall Improvement as Measured by Patient's Global Impression of Change
Time frame: Week 12
Use of Rescue Medication
Time frame: Baseline up to Week 12
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MD First Research - Chandler
Chandler, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Neuro-Pain Medical Center
Fresno, California, United States
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Boulder, Colorado, United States
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Largo, Florida, United States
Design Neuroscience Center
Miami Lakes, Florida, United States
Conquest Research - Orlando
Orlando, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Conquest Research
Winter Park, Florida, United States
...and 66 more locations
Pharmacokinetic (PK): Serum Concentration of LY3848575
Time frame: Baseline up to Week 12