Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia

NCT04662281 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: LX9211.1-202-PHN2020-004639-26
• Study Type: interventional
• Target: 79
• Locations: 3 countries
• Sites: 32

Brief Summary

Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS)

  ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicates a worse outcome. Negative change from baseline indicates no pain.

  Baseline (Week 2 of the Run-in period) to Week 6

Secondary Outcomes (8)

• Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6

  Baseline to Week 6

• Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6

  Baseline to Week 6

• Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6

  Baseline to Week 6

• Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI

  Baseline to Week 6

• Number of Participants Discontinuing Treatment Due to Lack of Efficacy Defined as Increase in ADPS From Baseline of ≥30% Based on Question 5 of the ZBPI

  Baseline to Week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

LX9211

EXPERIMENTAL

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.

Drug: LX9211

Interventions

Placebo DRUG

LX9211 matching-placebo, tablets will be administered orally.

Placebo

LX9211 DRUG

LX9211 tablets will be administered orally.

LX9211

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Postherpetic neuralgia (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (32)

Lexicon Investigational Site

Scottsdale, Arizona, 85258, United States

Location

Lexicon Investigational Site

Tucson, Arizona, 85741, United States

Location

Lexicon Investigational Site

Greenbrae, California, 94904, United States

Location

Lexicon Investigational Site

Brandon, Florida, 33511, United States

Location

Lexicon Investigational Site (113)

Miami, Florida, 33032, United States

Location

Lexicon Investigational Site

Miami, Florida, 33144, United States

Location

Lexicon Investigational Site

Miami, Florida, 33174, United States

Location

Lexicon Investigational Site

Ormond Beach, Florida, 32174, United States

Location

Lexicon Investigational Site

Winter Park, Florida, 32789, United States

Location

Lexicon Investigational Site (147)

Marietta, Georgia, 30060, United States

Location

Lexicon Investigational Site

Flossmoor, Illinois, 60422, United States

Location

Lexicon Investigational Site

Wauconda, Illinois, 60084, United States

Location

Lexicon Investigational Site

Boston, Massachusetts, 02131, United States

Location

Lexicon Investigational Site

Canton, Michigan, 48187, United States

Location

Lexicon Investigational Site

Hazelwood, Missouri, 63042, United States

Location

Lexicon Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Lexicon Investigational Site (148)

Cary, North Carolina, 27518, United States

Location

Lexicon Investigational Site

Jenkintown, Pennsylvania, 19046, United States

Location

Lexicon Investigational Site

Baytown, Texas, 77521, United States

Location

Lexicon Investigational Site

Victoria, Texas, 77901, United States

Location

Lexicon Investigational Site

Salt Lake City, Utah, 84102, United States

Location

Lexicon Investigational Site

Kenosha, Wisconsin, 53144, United States

Location

Lexicon Investigational Site (138)

Choceň, 565 01, Czechia

Location

Lexicon Investigational Site (140)

Pardubice, 53002, Czechia

Location

Lexicon Investigational Site (136)

Prague, 100 00 00, Czechia

Location

Lexicon Investigational Site (137)

Prague, 12000, Czechia

Location

Lexicon Investigational Site (141)

Prague, 13000, Czechia

Location

Lexicon Investigational Site (135)

Prague, 16000, Czechia

Location

Lexicon Investigational Site (128)

Katowice, 40-282, Poland

Location

Lexicon Investigational Site (130)

Katowice, 640-748, Poland

Location

Lexicon Investigational Site (134)

Lublin, 20-064, Poland

Location

Lexicon Investigational Site (133)

Warsaw, 01-868, Poland

Location

Related Publications (1)

• 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.

  PMID: 35257579 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Affairs
• Organization: Lexicon Pharmaceuticals, Inc.

medical-information@lexpharma.com

510-338-6064

Study Officials

• Suma Gopinathan, PhD

  Lexicon Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: December 10, 2020
• Primary Completion: November 18, 2022
• Study Completion: December 28, 2022
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

PL (4); US (22); CZ (6)