| Primary | 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. | The modified intent to treat (mITT) population included all randomized participants who had taken at least 1 dose of study drug. "Overall number of participants analyzed" is the number of participants analyzed in this outcome measure. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline (Week 2 of the Run-in period) to Week 6 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.62± 0.360
- OG001-2.42± 0.397
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The Mixed Model Repeated Measures (MMRM) model was used to assess the difference between LX9211 and placebo in the primary endpoint and it includes fixed effects of treatment, week, treatment-by-week interaction, the randomization strata of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate. | MMRM | | 0.120 | | Difference in Least Squares Means | -0.80 | | | 2-Sided | 95 | -1.82 | 0.21 | | | | | Superiority | | |
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| Secondary | 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. | The mITT population included all randomized participants who had taken at least 1 dose of study drug. "Overall number of participants analyzed" is the number of participants analyzed in this outcome measure. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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| Secondary | Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | 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 indicated a worse outcome. | The mITT population included all randomized participants who had taken at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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| Secondary | 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. | The mITT population included all randomized participants who had taken at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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| Secondary | 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 | 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. | The mITT population included all randomized participants who had taken at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies number of participants analyzed in this outcome measure. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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| Secondary | 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. | The mITT population included all randomized participants who had taken at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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| Secondary | 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. | The mITT population included all randomized participants who had taken at least 1 dose of study drug. "Overall number of participants analyzed" is the number of participants analyzed in this outcome measure. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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| Secondary | 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. | All enrolled participants. Participants who had at least a 30% reduction in pain intensity in ADPS at Week 6 were analyzed for this outcome measure. | Posted | | Median | Full Range | weeks | | Week 6 to Week 11 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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| Secondary | 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. | The safety population included those participants who took at least 1 dose of study drug during the Double-blind Treatment period. As per statistical analysis plan, the data for safety population is reported for the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period separately. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | Placebo (Double-blind Treatment Period) | Following a 2-week Single-blind Run-in period, participants received 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. | | OG001 | LX9211 (Double-blind Treatment Period) | Following a 2-week Single-blind Run-in period, participants received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6. |
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