Clinical trial NCT06203002: A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Official title: A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/


Eligibility criteria: Inclusion Criteria:

1. Participant has given written informed consent to participate in the study in accordance with local regulations
2. Adult male and female participants ≥18 years of age at the Screening Visit
3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening
4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
5. Pain from DPNP present for at least 6 months prior to Screening
6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
8. Willing to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion Criteria:

1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
2. History of neurolytic or neurosurgical therapy for DPNP
3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening

Primary outcomes:
measure: Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change from Baseline to Week 8 in Burning Pain
timeFrame: Baseline, Week 8
measure: Change from Baseline to Week 8 in Pain Interference on Sleep
timeFrame: Baseline, Week 8
measure: Patient Global Impression of Change (PGIC) Score at Week 8
timeFrame: Week 8
measure: Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Lexicon Investigational Site (128)
state: Alabama
city: Birmingham
country: United States
facility: Lexicon Investigational Site (222)
state: Alabama
city: Daphne
country: United States
facility: Lexicon Investigational Site (189)
state: Alabama
city: Guntersville
country: United States
facility: Lexicon Investigational Site (215)
state: Alabama
city: Chandler
country: United States
facility: Lexicon Investigational Site (115)
state: Arizona
city: Phoenix
country: United States
facility: Lexicon Investigational Site (195)
state: Arizona
city: Scottsdale
country: United States
facility: Lexicon Investigational Site (206)
state: Arizona
city: Tucson
country: United States
facility: Lexicon Investigational Site (102)
state: Arizona
city: Anaheim
country: United States
facility: Lexicon Investigational Site (107)
state: California
city: Canoga Park
country: United States
facility: Lexicon Investigational Site (173)
state: California
city: Escondido
country: United States
facility: Lexicon Investigational Site (179)
state: California
city: Fresno
country: United States
facility: Lexicon Investigational Site (161)
state: California
city: Greenbrae
country: United States
facility: Lexicon Investigational Site (112)
state: California
city: Huntington Beach
country: United States
facility: Lexicon Investigational Site (204)
state: California
city: Inglewood
country: United States
facility: Lexicon Investigational Site (191)
state: California
city: Lafayette
country: United States
facility: Lexicon Investigational Site (171)
state: California
city: Lomita
country: United States
facility: Lexicon Investigational Site (163)
state: California
city: Long Beach
country: United States
facility: Lexicon Investigational Site (169)
state: California
city: Sacramento
country: United States
facility: Lexicon Investigational Site (111)
state: California
city: Sacramento
country: United States
facility: Lexicon Investigational Site (126)
state: California
city: San Diego
country: United States
facility: Lexicon Investigational Site (129)
state: California
city: San Diego
country: United States
facility: Lexicon Investigational Site (154)
state: California
city: Tustin
country: United States
facility: Lexicon Investigational Site (124)
state: California
city: Vista
country: United States
facility: Lexicon Investigational Site (211)
state: California
city: Walnut Creek
country: United States
facility: Lexicon Investigational Site (181)
state: California
city: Brandon
country: United States
facility: Lexicon Investigational Site (119)
state: Florida
city: Brandon
country: United States
facility: Lexicon Investigational Site (194)
state: Florida
city: Daytona Beach
country: United States
facility: Lexicon Investigational Site (177)
state: Florida
city: Fleming Island
country: United States
facility: Lexicon Investigational Site (198)
state: Florida
city: Fort Myers
country: United States
facility: Lexicon Investigational Site (109)
state: Florida
city: Hollywood
country: United States
facility: Lexicon Investigational Site (180)
state: Florida
city: Jacksonville
country: United States
facility: Lexicon Investigational Site (188)
state: Florida
city: Miami
country: United States
facility: Lexicon Investigational Site (164)
state: Florida
city: New Port Richey
country: United States
facility: Lexicon Investigational Site (105)
state: Florida
city: Orlando
country: United States
facility: Lexicon Investigational Site (146)
state: Florida
city: Orlando
country: United States
facility: Lexicon Investigational Site (144)
state: Florida
city: Ormond Beach
country: United States
facility: Lexicon Investigational Site (123)
state: Florida
city: Plantation
country: United States
facility: Lexicon Investigational Site (182)
state: Florida
city: The Villages
country: United States
facility: Lexicon Investigational Site (133)
state: Florida
city: The Villages
country: United States
facility: Lexicon Investigational Site (138)
state: Florida
city: Winter Haven
country: United States
facility: Lexicon Investigational Site (131)
state: Florida
city: Winter Park
country: United States
facility: Lexicon Investigational Site (103)
state: Florida
city: Atlanta
country: United States
facility: Lexicon Investigational Site (150)
state: Georgia
city: Marietta
country: United States
facility: Lexicon Investigational Site (151)
state: Georgia
city: Berwyn
country: United States
facility: Lexicon Investigational Site (172)
state: Illinois
city: Flossmoor
country: United States
facility: Lexicon Investigational Site (132)
state: Illinois
city: El Dorado
country: United States
facility: Lexicon Investigational Site (185)
state: Kansas
city: Newton
country: United States
facility: Lexicon Investigational Site (178)
state: Kansas
city: Wichita
country: United States
facility: Lexicon Investigational Site (186)
state: Kansas
city: Owensboro
country: United States
facility: Lexicon Investigational Site (213)
state: Kentucky
city: New Orleans
country: United States
facility: Lexicon Investigational Site (170)
state: Louisiana
city: New Orleans
country: United States
facility: Lexicon Investigational Site (190)
state: Louisiana
city: Boston
country: United States
facility: Lexicon Investigational Site (121)
state: Massachusetts
city: New Bedford
country: United States
facility: Lexicon Investigational Site (140)
state: Massachusetts
city: Waltham
country: United States
facility: Lexicon Investigational Site (225)
state: Massachusetts
city: Ann Arbor
country: United States
facility: Lexicon Investigational Site (125)
state: Michigan
city: Dearborn
country: United States
facility: Lexicon Investigational Site (108)
state: Michigan
city: Olive Branch
country: United States
facility: Lexicon Investigational Site (139)
state: Mississippi
city: Hazelwood
country: United States
facility: Lexicon Investigational Site (104)
state: Missouri
city: Kansas City
country: United States
facility: Lexicon Investigational Site (174)
state: Missouri
city: Saint Louis
country: United States
facility: Lexicon Investigational Site (156)
state: Missouri
city: Springfield
country: United States
facility: Lexicon Investigational Site (184)
state: Missouri
city: Papillion
country: United States
facility: Lexicon Investigational Site (116)
state: Nebraska
city: Las Vegas
country: United States
facility: Lexicon Investigational Site (216)
state: Nevada
city: Las Vegas
country: United States
facility: Lexicon Investigational Site (162)
state: Nevada
city: New York
country: United States
facility: Lexicon Investigational Site (142)
state: New York
city: Rochester
country: United States
facility: Lexicon Investigational Site (227)
state: New York
city: Schenectady
country: United States
facility: Lexicon Investigational Site (167)
state: New York
city: Westfield
country: United States
facility: Lexicon Investigational Site (122)
state: New York
city: Williamsville
country: United States
facility: Lexicon Investigational Site (110)
state: New York
city: Asheville
country: United States
facility: Lexicon Investigational Site (200)
state: North Carolina
city: Greensboro
country: United States
facility: Lexicon Investigational Site (209)
state: North Carolina
city: Monroe
country: United States
facility: Lexicon Investigational Site (212)
state: North Carolina
city: Morehead City
country: United States
facility: Lexicon Investigational Site (106)
state: North Carolina
city: Winston-Salem
country: United States
facility: Lexicon Investigational Site (145)
state: North Carolina
city: Beavercreek
country: United States
facility: Lexicon Investigational Site (220)
state: Ohio
city: Dayton
country: United States
facility: Lexicon Investigational Site (168)
state: Ohio
city: Norman
country: United States
facility: Lexicon Investigational Site (148)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lexicon Investigational Site (210)
state: Oklahoma
city: Eugene
country: United States
facility: Lexicon Investigational Site (187)
state: Oregon
city: Charleston
country: United States
facility: Lexicon Investigational Site (183)
state: South Carolina
city: Columbia
country: United States
facility: Lexicon Investigational Site (201)
state: South Carolina
city: Greenville
country: United States
facility: Lexicon Investigational Site (113)
state: South Carolina
city: North Charleston
country: United States
facility: Lexicon Investigational Site (205)
state: South Carolina
city: Rock Hill
country: United States
facility: Lexicon Investigational Site (202)
state: South Carolina
city: Summerville
country: United States
facility: Lexicon Investigational Site (157)
state: South Carolina
city: Memphis
country: United States
facility: Lexicon Investigational Site (160)
state: Tennessee
city: Austin
country: United States
facility: Lexicon Investigational Site (192)
state: Texas
city: Baytown
country: United States
facility: Lexicon Investigational Site (199)
state: Texas
city: Dallas
country: United States
facility: Lexicon Investigational Site (193)
state: Texas
city: Dallas
country: United States
facility: Lexicon Investigational Site (158)
state: Texas
city: Euless
country: United States
facility: Lexicon Investigational Site (153)
state: Texas
city: Flower Mound
country: United States
facility: Lexicon Investigational Site (114)
state: Texas
city: Harlingen
country: United States
facility: Lexicon Investigational Site (196)
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site (120)
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site (197)
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site (152)
state: Texas
city: Katy
country: United States
facility: Lexicon Investigational Site (214)
state: Texas
city: Lewisville
country: United States
facility: Lexicon Investigational Site (155)
state: Texas
city: Mesquite
country: United States
facility: Lexicon Investigational Site (223)
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site (203)
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site (159)
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site (221)
state: Texas
city: Saint George
country: United States
facility: Lexicon Investigational Site (224)
state: Utah
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site (101)
state: Utah
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site (219)
state: Utah
city: Manassas
country: United States
facility: Lexicon Investigational Site (130)
state: Virginia
city: Norfolk
country: United States
facility: Lexicon Investigational Site (165)
state: Virginia
Study officials:
References: