Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
NCT ID: NCT04662281
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2020-12-29
2022-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Following a 2-week Single-blind Run-in period, participants will receive a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
Placebo
LX9211 matching-placebo, tablets will be administered orally.
LX9211
Following a 2-week Single-blind Run-in period, participants will receive a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
LX9211
LX9211, 200 mg, tablets will be administered orally.
Interventions
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Placebo
LX9211 matching-placebo, tablets will be administered orally.
LX9211
LX9211, 200 mg, tablets will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Suma Gopinathan, PhD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals
Locations
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Lexicon Investigational Site
Scottsdale, Arizona, United States
Lexicon Investigational Site
Tucson, Arizona, United States
Lexicon Investigational Site
Greenbrae, California, United States
Lexicon Investigational Site
Brandon, Florida, United States
Lexicon Investigational Site (113)
Miami, Florida, United States
Lexicon Investigational Site
Miami, Florida, United States
Lexicon Investigational Site
Miami, Florida, United States
Lexicon Investigational Site
Ormond Beach, Florida, United States
Lexicon Investigational Site
Winter Park, Florida, United States
Lexicon Investigational Site (147)
Marietta, Georgia, United States
Lexicon Investigational Site
Flossmoor, Illinois, United States
Lexicon Investigational Site
Wauconda, Illinois, United States
Lexicon Investigational Site
Boston, Massachusetts, United States
Lexicon Investigational Site
Canton, Michigan, United States
Lexicon Investigational Site
Hazelwood, Missouri, United States
Lexicon Investigational Site
Albuquerque, New Mexico, United States
Lexicon Investigational Site (148)
Cary, North Carolina, United States
Lexicon Investigational Site
Jenkintown, Pennsylvania, United States
Lexicon Investigational Site
Baytown, Texas, United States
Lexicon Investigational Site
Victoria, Texas, United States
Lexicon Investigational Site
Salt Lake City, Utah, United States
Lexicon Investigational Site
Kenosha, Wisconsin, United States
Lexicon Investigational Site (138)
Choceň, , Czechia
Lexicon Investigational Site (140)
Pardubice, , Czechia
Lexicon Investigational Site (136)
Prague, , Czechia
Lexicon Investigational Site (137)
Prague, , Czechia
Lexicon Investigational Site (141)
Prague, , Czechia
Lexicon Investigational Site (135)
Prague, , Czechia
Lexicon Investigational Site (128)
Katowice, , Poland
Lexicon Investigational Site (130)
Katowice, , Poland
Lexicon Investigational Site (134)
Lublin, , Poland
Lexicon Investigational Site (133)
Warsaw, , Poland
Countries
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References
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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.
Other Identifiers
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2020-004639-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LX9211.1-202-PHN
Identifier Type: -
Identifier Source: org_study_id
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