Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia

Lexicon Pharmaceuticals79 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postherpetic Neuralgia

Interventions

PlaceboDRUG

LX9211 matching-placebo, tablets will be administered orally.

LX9211DRUG

LX9211 tablets will be administered orally.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * 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 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

Locations (32)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

Pain interfering with sleep is based on Question 9F of the ZBPI "Indicate the one number that describes how, in the past 24-hours shingles pain has interfered with your: Sleep; 0 = does not interfere to 10 = Completely interferes. Higher the number, the worsening of sleep due to pain interference. Negative change from baseline indicates no interference in sleep. Pain interfering with sleep was based on the daily pain diary data based on Q 9F of the ZBPI.

Time frame: Baseline to Week 6

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

Time frame: Baseline to Week 6

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

ADPS is based on question 5 of 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 indicated a worse outcome.

Time frame: 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

Data from ClinicalTrials.gov

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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

...and 22 more locations

The ZBPI, a 9-item questionnaire, assesses the severity of pain and its impact on functioning in participants with postherpetic neuralgia (PHN). Each question concerning daily activity (General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life) was scored on a scale from 0 to 10, where 0 indicated no interference and 10 indicated complete interference. Higher ZBPI score indicates a worse outcome. Negative change from baseline indicates no interference in all daily activities. The pain interference at Week 6 in this outcome measure was based on data collected on the ZBPI administered at the Week 6 in-person clinic visit.

Time frame: 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

ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.

Time frame: Baseline to Week 6

Patient Global Impression of Change (PGIC) at Week 6

PGIC is assessed on a 7-point rating scale where 1= very much improved to 7 = very much worse. Higher scores indicate worse outcomes.

Time frame: Baseline to Week 6

Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving ≥30% Reduction in Pain Intensity in ADPS Based on Question 5 of the ZBPI.

ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.

Time frame: Week 6 to Week 11

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Adverse Events (AEs) are defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs reported after the first dose of double-blind study medication on study Day 1.

Time frame: From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)