Clinical trial NCT04662281: Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX9211 in the Treatment of Postherpetic Neuralgia (RELIEF-PHN1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 79
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 pain related to postherpetic neuralgia over an 11 week assessment period.


Eligibility criteria: Inclusion Criteria:

* 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 time of screening
* PHN pain that is present for ≥3 months after healing of herpes zoster skin rash affecting a single dermatome (Participants with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous)
* Moderate to severe pain as confirmed by average pain score using scores recorded in the pain diary in the 14 days prior to randomization

Exclusion Criteria:

* Presence of other painful conditions that may confound assessment or self-evaluation of PHN
* History of major depressive episode, active, significant psychiatric disorders
* History of clinically significant drug or alcohol use disorder
* PHN affecting the face
* Use of opioid medications for management of PHN within the 2 months prior to Screening Visit
* Use of Non-steroidal anti-inflammatory drugs (NSAIDs) for the specific treatment of PHN pain

Primary outcomes:
measure: Change from Baseline in Average Daily Pain Score (ADPS)
timeFrame: Day 1 to Week 6
Secondary outcomes:
measure: ≥30 percent reduction in pain intensity
timeFrame: Day 1 to Week 6
measure: ≥50 percent reduction in pain intensity
timeFrame: Day 1 to Week 6
measure: Safety: number of AEs reported
timeFrame: Day 1 to Week 6
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Lexicon Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Lexicon Investigational Site
state: Arizona
city: Greenbrae
country: United States
facility: Lexicon Investigational Site
state: California
city: Brandon
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Miami
country: United States
facility: Lexicon Investigational Site (113)
state: Florida
city: Miami
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Miami
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: Marietta
country: United States
facility: Lexicon Investigational Site (147)
state: Georgia
city: Flossmoor
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Wauconda
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Boston
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Canton
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Hazelwood
country: United States
facility: Lexicon Investigational Site
state: Missouri
city: Albuquerque
country: United States
facility: Lexicon Investigational Site
state: New Mexico
city: Cary
country: United States
facility: Lexicon Investigational Site (148)
state: North Carolina
city: Jenkintown
country: United States
facility: Lexicon Investigational Site
state: Pennsylvania
city: Baytown
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Victoria
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Kenosha
country: United States
facility: Lexicon Investigational Site
state: Wisconsin
city: Choceň
country: Czechia
facility: Lexicon Investigational Site (138)
city: Pardubice
country: Czechia
facility: Lexicon Investigational Site (140)
city: Praha
country: Czechia
facility: Lexicon Investigational Site (136)
city: Praha
country: Czechia
facility: Lexicon Investigational Site (137)
city: Praha
country: Czechia
facility: Lexicon Investigational Site (141)
city: Praha
country: Czechia
facility: Lexicon Investigational Site (135)
city: Katowice
country: Poland
facility: Lexicon Investigational Site (128)
city: Katowice
country: Poland
facility: Lexicon Investigational Site (130)
city: Lublin
country: Poland
facility: Lexicon Investigational Site (134)
city: Warsaw
country: Poland
facility: Lexicon Investigational Site (133)
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.