Trial · NCT04662281
Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
NCT04662281, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2026-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia. Trials, record NCT04662281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04662281
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
- NCT number
- NCT04662281
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Postherpetic Neuralgia
- Interventions
- Placebo, LX9211
- First posted
- 2020-12-10
- Last updated
- 2026-02-13
- Other registries' IDs
- eudract:2020-004639-26
- Results first posted
- 2026-02-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS) | Baseline (Week 2 of the Run-in period) to 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 indicates a worse outcome. Negative change from baseline indicates no pain. |
| Secondary | Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6 | Baseline to 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. |
| Secondary | Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | Baseline to 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. |
| Secondary | Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | Baseline to 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. |
| 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 | Baseline to Week 6 | 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. |
| 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 | Baseline to 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. |
| Secondary | Patient Global Impression of Change (PGIC) at Week 6 | Baseline to 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. |
| 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. | Week 6 to Week 11 | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS) | Baseline (Week 2 of the Run-in period) to Week 6 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6 | Baseline to Week 6 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | Baseline to Week 6 | The mITT population included all randomized participants who had taken at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | Baseline to Week 6 | The mITT population included all randomized participants who had taken at least 1 dose of study drug. | percentage of participants | NUMBER |
| 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 | Baseline to Week 6 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 6 | The mITT population included all randomized participants who had taken at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Global Impression of Change (PGIC) at Week 6 | Baseline to Week 6 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| 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. | Week 6 to Week 11 | 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. | weeks | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS) | Placebo | -1.62 | Standard Error 0.360 | score on a scale | |
| Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS) | LX9211 | -2.42 | Standard Error 0.397 | score on a scale | |
| Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6 | Placebo | -1.43 | Standard Error 0.323 | score on a scale | |
| Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6 | LX9211 | -2.04 | Standard Error 0.364 | score on a scale | |
| Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | Placebo | 34.15 | percentage of participants | ||
| Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | LX9211 | 42.11 | percentage of participants | ||
| Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | Placebo | 19.51 | percentage of participants | ||
| Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | LX9211 | 23.68 | percentage of participants | ||
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 | Placebo | General Activity: Change at Week 6 | -0.52 | Standard Error 0.392 | score on a scale |
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 | LX9211 | General Activity: Change at Week 6 | -1.75 | Standard Error 0.417 | score on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | STARTED | LX9211 | 38 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | COMPLETED | LX9211 | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | LX9211 | 17 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Placebo (Double-blind Treatment Period) | 0 | 41 | |
| other | Vertigo | Ear and labyrinth disorders | LX9211 (Double-blind Treatment Period) | 2 | 38 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo (Single-blind Placebo Safety Follow-up Period) | 0 | 38 | |
| other | Vertigo | Ear and labyrinth disorders | LX9211 (Single-blind Placebo Safety Follow-up Period) | 0 | 31 | |
| other | Constipation | Gastrointestinal disorders | Placebo (Double-blind Treatment Period) | 0 | 41 | |
| other | Constipation | Gastrointestinal disorders | LX9211 (Double-blind Treatment Period) | 4 | 38 | |
| other | Constipation | Gastrointestinal disorders | Placebo (Single-blind Placebo Safety Follow-up Period) | 0 | 38 | |
| other | Constipation | Gastrointestinal disorders | LX9211 (Single-blind Placebo Safety Follow-up Period) | 0 | 31 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo (Double-blind Treatment Period) | 3 | 41 | |
| other | Diarrhea | Gastrointestinal disorders | LX9211 (Double-blind Treatment Period) | 0 | 38 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Double-blind Treatment Period) | 0 | 41 |
| Total, all-cause mortality | LX9211 (Double-blind Treatment Period) | 0 | 38 |
| Total, all-cause mortality | Placebo (Single-blind Placebo Safety Follow-up Period) | 0 | 38 |
| Total, all-cause mortality | LX9211 (Single-blind Placebo Safety Follow-up Period) | 0 | 31 |
| Total, other adverse events | Placebo (Double-blind Treatment Period) | 6 | 41 |
| Total, other adverse events | LX9211 (Double-blind Treatment Period) | 24 | 38 |
| Total, other adverse events | Placebo (Single-blind Placebo Safety Follow-up Period) | 2 | 38 |
| Total, other adverse events | LX9211 (Single-blind Placebo Safety Follow-up Period) | 1 | 31 |
| Total, serious adverse events | Placebo (Double-blind Treatment Period) | 0 | 41 |
| Total, serious adverse events | LX9211 (Double-blind Treatment Period) | 0 | 38 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35257579 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LX9211 vs Placebo: 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 |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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