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Efficacy and Safety of LX9211 in Patients With Postherpetic Neuralgia (RELIEF-PHN1)

Primary Purpose

Postherpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LX9211
Placebo
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • PHN pain that is present for ≥3 months after healing of herpes zoster skin rash affecting a single dermatome (Patients 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 NSAIDs for the specific treatment of PHN pain

Sites / Locations

  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (113)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (147)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (148)
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site (138)
  • Lexicon Investigational Site (140)
  • Lexicon Investigational Site (136)
  • Lexicon Investigational Site (137)
  • Lexicon Investigational Site (141)
  • Lexicon Investigational Site (135)
  • Lexicon Investigational Site (128)
  • Lexicon Investigational Site (130)
  • Lexicon Investigational Site (134)
  • Lexicon Investigational Site (133)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LX9211

Placebo

Arm Description

LX9211, once daily

Placebo, once daily

Outcomes

Primary Outcome Measures

Change from Baseline in Average Daily Pain Score (ADPS)
The change from Baseline (Week 2) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (0 [No Pain] to 10 [Pain as bad as you can imagine])

Secondary Outcome Measures

≥30 percent reduction in pain intensity
Proportion of patients with ≥30% reduction in pain intensity
≥50 percent reduction in pain intensity
Proportion of patients with ≥50% reduction in pain intensity
Safety: number of AEs reported
Number of Adverse Events

Full Information

First Posted
December 4, 2020
Last Updated
March 24, 2023
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04662281
Brief Title
Efficacy and Safety of LX9211 in Patients With Postherpetic Neuralgia
Acronym
RELIEF-PHN1
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LX9211
Arm Type
Experimental
Arm Description
LX9211, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, once daily
Intervention Type
Drug
Intervention Name(s)
LX9211
Intervention Description
11-week assessment period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
11-week assessment period
Primary Outcome Measure Information:
Title
Change from Baseline in Average Daily Pain Score (ADPS)
Description
The change from Baseline (Week 2) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (0 [No Pain] to 10 [Pain as bad as you can imagine])
Time Frame
Day 1 to Week 6
Secondary Outcome Measure Information:
Title
≥30 percent reduction in pain intensity
Description
Proportion of patients with ≥30% reduction in pain intensity
Time Frame
Day 1 to Week 6
Title
≥50 percent reduction in pain intensity
Description
Proportion of patients with ≥50% reduction in pain intensity
Time Frame
Day 1 to Week 6
Title
Safety: number of AEs reported
Description
Number of Adverse Events
Time Frame
Day 1 to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 PHN pain that is present for ≥3 months after healing of herpes zoster skin rash affecting a single dermatome (Patients 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 NSAIDs for the specific treatment of PHN pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suma Gopinathan, PhD
Organizational Affiliation
Lexicon Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Lexicon Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Lexicon Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Lexicon Investigational Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Lexicon Investigational Site (113)
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Lexicon Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Lexicon Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Lexicon Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Lexicon Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Lexicon Investigational Site (147)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Lexicon Investigational Site
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Lexicon Investigational Site
City
Wauconda
State/Province
Illinois
ZIP/Postal Code
60084
Country
United States
Facility Name
Lexicon Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Lexicon Investigational Site
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Facility Name
Lexicon Investigational Site
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Lexicon Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Lexicon Investigational Site (148)
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Lexicon Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Lexicon Investigational Site
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Lexicon Investigational Site
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Lexicon Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Lexicon Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Facility Name
Lexicon Investigational Site (138)
City
Choceň
ZIP/Postal Code
565 01
Country
Czechia
Facility Name
Lexicon Investigational Site (140)
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Lexicon Investigational Site (136)
City
Praha
ZIP/Postal Code
100 00 00
Country
Czechia
Facility Name
Lexicon Investigational Site (137)
City
Praha
ZIP/Postal Code
12000
Country
Czechia
Facility Name
Lexicon Investigational Site (141)
City
Praha
ZIP/Postal Code
13000
Country
Czechia
Facility Name
Lexicon Investigational Site (135)
City
Praha
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Lexicon Investigational Site (128)
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Lexicon Investigational Site (130)
City
Katowice
ZIP/Postal Code
640-748
Country
Poland
Facility Name
Lexicon Investigational Site (134)
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Lexicon Investigational Site (133)
City
Warsaw
ZIP/Postal Code
01-868
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Citations:
PubMed Identifier
35257579
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.
Results Reference
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Efficacy and Safety of LX9211 in Patients With Postherpetic Neuralgia

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