A Dose-ranging Study in Patients with Diabetic Peripheral Neuropathic Pain (DPNP)
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- Drug: LX9211 (blinded)Drug: Placebo (blinded)
- Registration Number
- NCT06203002
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 416
- Participant has given written informed consent to participate in the study in accordance with local regulations
- Adult male and female participants ≥18 years of age at the Screening Visit
- Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2) at Screening
- Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
- Pain from DPNP present for at least 6 months prior to Screening
- At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
- Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
- Willing to adhere to the prohibitions and restrictions specified in the protocol.
- Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- History of neurolytic or neurosurgical therapy for DPNP
- Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
- Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LX9211 High Dose LX9211 (blinded) LX9211 high dose, orally, once daily during a blinded treatment period. LX9211 Placebo Placebo (blinded) LX9211 matching placebo, orally, once daily during a blinded treatment period. LX9211 Low Dose LX9211 (blinded) LX9211 low dose, orally, once daily during a blinded treatment period. LX9211 High Dose Followed by Low Dose LX9211 (blinded) LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 8 in Average Daily Pain Score (ADPS) Baseline, Week 8 ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score Baseline, Week 8 NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome.
Patient Global Impression of Change (PGIC) Score at Week 8 Week 8 The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse.
Change from Baseline to Week 8 in Pain Interference on Sleep Baseline, Week 8 Pain interference on sleep is based on the 11-point NRS (0 \[does not interfere\] to 10 \[completely interferes\]).
Change from Baseline to Week 8 in Burning Pain Baseline, Week 8 Burning pain is based on the 11-point NRS (0 \[no burning\] to 10 \[worst burning imaginable\]).
Trial Locations
- Locations (108)
Lexicon Investigational Site (128)
🇺🇸Anniston, Alabama, United States
Lexicon Investigational Site (222)
🇺🇸Birmingham, Alabama, United States
Lexicon Investigational Site (189)
🇺🇸Daphne, Alabama, United States
Lexicon Investigational Site (215)
🇺🇸Guntersville, Alabama, United States
Lexicon Investigational Site (115)
🇺🇸Chandler, Arizona, United States
Lexicon Investigational Site (195)
🇺🇸Phoenix, Arizona, United States
Lexicon Investigational Site (206)
🇺🇸Scottsdale, Arizona, United States
Lexicon Investigational Site (102)
🇺🇸Tucson, Arizona, United States
Lexicon Investigational Site (107)
🇺🇸Anaheim, California, United States
Lexicon Investigational Site (173)
🇺🇸Canoga Park, California, United States
Lexicon Investigational Site (179)
🇺🇸Escondido, California, United States
Lexicon Investigational Site (161)
🇺🇸Fresno, California, United States
Lexicon Investigational Site (112)
🇺🇸Greenbrae, California, United States
Lexicon Investigational Site (204)
🇺🇸Huntington Beach, California, United States
Lexicon Investigational Site (191)
🇺🇸Inglewood, California, United States
Lexicon Investigational Site (171)
🇺🇸Lafayette, California, United States
Lexicon Investigational Site (163)
🇺🇸Lomita, California, United States
Lexicon Investigational Site (169)
🇺🇸Long Beach, California, United States
Lexicon Investigational Site (111)
🇺🇸Sacramento, California, United States
Lexicon Investigational Site (126)
🇺🇸Sacramento, California, United States
Lexicon Investigational Site (129)
🇺🇸San Diego, California, United States
Lexicon Investigational Site (154)
🇺🇸San Diego, California, United States
Lexicon Investigational Site (124)
🇺🇸Tustin, California, United States
Lexicon Investigational Site (211)
🇺🇸Vista, California, United States
Lexicon Investigational Site (181)
🇺🇸Walnut Creek, California, United States
Lexicon Investigational Site (119)
🇺🇸Brandon, Florida, United States
Lexicon Investigational Site (194)
🇺🇸Brandon, Florida, United States
Lexicon Investigational Site (177)
🇺🇸Daytona Beach, Florida, United States
Lexicon Investigational Site (198)
🇺🇸Fleming Island, Florida, United States
Lexicon Investigational Site (109)
🇺🇸Ft. Myers, Florida, United States
Lexicon Investigational Site (180)
🇺🇸Hollywood, Florida, United States
Lexicon Investigational Site (188)
🇺🇸Jacksonville, Florida, United States
Lexicon Investigational Site (164)
🇺🇸Miami, Florida, United States
Lexicon Investigational Site (105)
🇺🇸New Port Richey, Florida, United States
Lexicon Investigational Site (146)
🇺🇸Orlando, Florida, United States
Lexicon Investigational Site (144)
🇺🇸Orlando, Florida, United States
Lexicon Investigational Site (123)
🇺🇸Ormond Beach,, Florida, United States
Lexicon Investigational Site (182)
🇺🇸Plantation, Florida, United States
Lexicon Investigational Site (133)
🇺🇸The Villages, Florida, United States
Lexicon Investigational Site (138)
🇺🇸The Villages, Florida, United States
Lexicon Investigational Site (131)
🇺🇸Winter Haven, Florida, United States
Lexicon Investigational Site (103)
🇺🇸Winter Park, Florida, United States
Lexicon Investigational Site (150)
🇺🇸Atlanta, Georgia, United States
Lexicon Investigational Site (151)
🇺🇸Marietta, Georgia, United States
Lexicon Investigational Site (172)
🇺🇸Berwyn, Illinois, United States
Lexicon Investigational Site (132)
🇺🇸Flossmoor, Illinois, United States
Lexicon Investigational Site (185)
🇺🇸El Dorado, Kansas, United States
Lexicon Investigational Site (178)
🇺🇸Newton, Kansas, United States
Lexicon Investigational Site (186)
🇺🇸Wichita, Kansas, United States
Lexicon Investigational Site (213)
🇺🇸Owensboro, Kentucky, United States
Lexicon Investigational Site (170)
🇺🇸New Orleans, Louisiana, United States
Lexicon Investigational Site (190)
🇺🇸New Orleans, Louisiana, United States
Lexicon Investigational Site (121)
🇺🇸Boston, Massachusetts, United States
Lexicon Investigational Site (140)
🇺🇸New Bedford, Massachusetts, United States
Lexicon Investigational Site (225)
🇺🇸Waltham, Massachusetts, United States
Lexicon Investigational Site (125)
🇺🇸Ann Arbor, Michigan, United States
Lexicon Investigational Site (108)
🇺🇸Dearborn, Michigan, United States
Lexicon Investigational Site (139)
🇺🇸Olive Branch, Mississippi, United States
Lexicon Investigational Site (104)
🇺🇸Hazelwood, Missouri, United States
Lexicon Investigational Site (174)
🇺🇸Kansas City, Missouri, United States
Lexicon Investigational Site (156)
🇺🇸Saint Louis, Missouri, United States
Lexicon Investigational Site (184)
🇺🇸Springfield, Missouri, United States
Lexicon Investigational Site (116)
🇺🇸Papillion, Nebraska, United States
Lexicon Investigational Site (216)
🇺🇸Las Vegas, Nevada, United States
Lexicon Investigational Site (162)
🇺🇸Las Vegas, Nevada, United States
Lexicon Investigational Site (142)
🇺🇸New York, New York, United States
Lexicon Investigational Site (227)
🇺🇸Rochester, New York, United States
Lexicon Investigational Site (167)
🇺🇸Schenectady, New York, United States
Lexicon Investigational Site (122)
🇺🇸Westfield, New York, United States
Lexicon Investigational Site (110)
🇺🇸Williamsville, New York, United States
Lexicon Investigational Site (200)
🇺🇸Asheville, North Carolina, United States
Lexicon Investigational Site (209)
🇺🇸Greensboro, North Carolina, United States
Lexicon Investigational Site (212)
🇺🇸Monroe, North Carolina, United States
Lexicon Investigational Site (106)
🇺🇸Morehead City, North Carolina, United States
Lexicon Investigational Site (145)
🇺🇸Winston-Salem, North Carolina, United States
Lexicon Investigational Site (220)
🇺🇸Beavercreek, Ohio, United States
Lexicon Investigational Site (160)
🇺🇸Memphis, Tennessee, United States
Lexicon Investigational Site (192)
🇺🇸Austin, Texas, United States
Lexicon Investigational Site (199)
🇺🇸Baytown, Texas, United States
Lexicon Investigational Site (168)
🇺🇸Dayton, Ohio, United States
Lexicon Investigational Site (148)
🇺🇸Norman, Oklahoma, United States
Lexicon Investigational Site (210)
🇺🇸Oklahoma City, Oklahoma, United States
Lexicon Investigational Site (187)
🇺🇸Eugene, Oregon, United States
Lexicon Investigational Site (183)
🇺🇸Charleston, South Carolina, United States
Lexicon Investigational Site (201)
🇺🇸Columbia, South Carolina, United States
Lexicon Investigational Site (113)
🇺🇸Greenville, South Carolina, United States
Lexicon Investigational Site (205)
🇺🇸North Charleston, South Carolina, United States
Lexicon Investigational Site (202)
🇺🇸Rock Hill, South Carolina, United States
Lexicon Investigational Site (157)
🇺🇸Summerville, South Carolina, United States
Lexicon Investigational Site (193)
🇺🇸Dallas, Texas, United States
Lexicon Investigational Site (158)
🇺🇸Dallas, Texas, United States
Lexicon Investigational Site (153)
🇺🇸Euless, Texas, United States
Lexicon Investigational Site (114)
🇺🇸Flower Mound, Texas, United States
Lexicon Investigational Site (196)
🇺🇸Harlingen, Texas, United States
Lexicon Investigational Site (120)
🇺🇸Houston, Texas, United States
Lexicon Investigational Site (197)
🇺🇸Houston, Texas, United States
Lexicon Investigational Site (152)
🇺🇸Houston, Texas, United States
Lexicon Investigational Site (214)
🇺🇸Katy, Texas, United States
Lexicon Investigational Site (155)
🇺🇸Lewisville, Texas, United States
Lexicon Investigational Site (223)
🇺🇸Mesquite, Texas, United States
Lexicon Investigational Site (203)
🇺🇸San Antonio, Texas, United States
Lexicon Investigational Site (159)
🇺🇸San Antonio, Texas, United States
Lexicon Investigational Site (221)
🇺🇸San Antonio, Texas, United States
Lexicon Investigational Site (101)
🇺🇸Salt Lake City, Utah, United States
Lexicon Investigational Site (219)
🇺🇸Salt Lake City, Utah, United States
Lexicon Investigational Site (224)
🇺🇸St. George, Utah, United States
Lexicon Investigational Site (130)
🇺🇸Manassas, Virginia, United States
Lexicon Investigational Site (165)
🇺🇸Norfolk, Virginia, United States