The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Time frame: Baseline, Week 8
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
Time frame: Baseline, Week 8
Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C)
Time frame: Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS
Time frame: Baseline, Week 8
Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Time frame: Baseline, Week 8
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)
Time frame: Baseline, Week 8
Total Amount of Rescue Medication Used Daily During the Treatment Phase
Time frame: Week 8
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Central Research Associates
Birmingham, Alabama, United States
RECRUITINGSynexus Clinical Research US, Inc.
Phoenix, Arizona, United States
RECRUITINGArizona Research Center
Phoenix, Arizona, United States
RECRUITINGDesert Oasis Healthcare Medical Group
Palm Springs, California, United States
RECRUITINGArtemis Institute for Clinical Research
Riverside, California, United States
RECRUITINGArtemis Institute for Clinical Research
San Diego, California, United States
RECRUITINGCMR of Greater New Haven
Hamden, Connecticut, United States
RECRUITINGBradenton Research Center, Inc.
Bradenton, Florida, United States
RECRUITINGAccel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
RECRUITINGK2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, United States
RECRUITING...and 27 more locations