Clinical trial NCT04455633: Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Diabetes
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-07-02
Enrollment: 319
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 a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period.


Eligibility criteria: Inclusion Criteria:

* Patient has given written informed consent to participate in the study in accordance with local regulations
* Adult male and female patients ≥18 years of age at the time of screening
* Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
* Diagnosis of DPNP at Screening
* Pain from DPN present for at least 6 months
* A1C ≤11% at screening
* Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening

Exclusion Criteria:

* Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
* History of major depressive episode, active, significant psychiatric disorders
* History of clinically significant drug or alcohol use disorder
* History of neurolytic or neurosurgical therapy for DPNP
* Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
* Use of NSAIDs less than 2 weeks prior to the Screening Visit

Primary outcomes:
measure: Change from Baseline in Average Daily Pain Score (ADPS)
timeFrame: Day 1 to Week 6
Secondary outcomes:
measure: ≥30% reduction in pain intensity
timeFrame: Day 1 to Week 6
measure: ≥50% reduction in pain intensity
timeFrame: Day 1 to Week 6
measure: Safety: # of AEs reported
timeFrame: Day 1 to Week 6
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Lexicon Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Lexicon Investigational Site (156)
state: Arizona
city: Glendale
country: United States
facility: Lexicon Investigational Site
state: Arizona
city: Kingman
country: United States
facility: Lexicon Investigational Site (162)
state: Arizona
city: Tucson
country: United States
facility: Lexicon Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Lexicon Investigational Site
state: California
city: Greenbrae
country: United States
facility: Lexicon Investigational Site
state: California
city: Los Angeles
country: United States
facility: Lexicon Investigational Site (167)
state: California
city: North Hollywood
country: United States
facility: Lexicon Investigational Site
state: California
city: Sacramento
country: United States
facility: Lexicon Investigational Site
state: California
city: Tustin
country: United States
facility: Lexicon Investigational Site
state: California
city: Brandon
country: United States
facility: Lexicon Investigational Site (140)
state: Florida
city: Fort Myers
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Lexicon Investigational Site (154)
state: Florida
city: Lake City
country: United States
facility: Lexicon Investigational Site (157)
state: Florida
city: Lake City
country: United States
facility: Lexicon Investigational Site (166)
state: Florida
city: New Port Richey
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Macon
country: United States
facility: Lexicon Investigational Site (163)
state: Georgia
city: Evansville
country: United States
facility: Lexicon Investigational Site
state: Indiana
city: Boston
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: South Dartmouth
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Dearborn
country: United States
facility: Lexicon Investigational Site (151)
state: Michigan
city: Farmington Hills
country: United States
facility: Lexicon Investigational Site (150)
state: Michigan
city: Sterling Heights
country: United States
facility: Lexicon Investigational Site (159)
state: Michigan
city: Hazelwood
country: United States
facility: Lexicon Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Lexicon Investigational Site
state: Nebraska
city: Berlin
country: United States
facility: Lexicon Investigational Site
state: New Jersey
city: Westfield
country: United States
facility: Lexicon Investigational Site
state: New York
city: Williamsville
country: United States
facility: Lexicon Investigational Site
state: New York
city: Asheville
country: United States
facility: Lexicon Investigational Site (153)
state: North Carolina
city: Cary
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Lexicon Investigational Site (149)
state: South Carolina
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Flower Mound
country: United States
facility: Lexicon Investigational Site (168)
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Pearland
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Renton
country: United States
facility: Lexicon Investigational Site
state: Washington
Study officials:
affiliation: Lexicon Pharmaceuticals
name: Suma Gopinathan, PhD
role: STUDY_DIRECTOR
References:
citation: Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8.