Phase 2
N=79
Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
Postherpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT04662281 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS) — -1.62; -2.42 score on a scale — p=0.120
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); LX9211 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lexicon Pharmaceuticals
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS) |
-1.62; -2.42 | 0.120 |
| SECONDARY Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6 |
-1.43; -2.04 | 0.181 |
| SECONDARY Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6 |
34.15; 42.11 | 0.504 |
| SECONDARY Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 |
19.51; 23.68 | 0.671 |
| 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 |
-0.52; -1.75; -1.52; -2.36; -0.28; -0.72 | 0.024 sig |
| 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 |
1; 0 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 6 |
3.06; 2.65 | 0.192 |
| 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. |
NA; NA | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
13; 24; 9; 5 | — |
Summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04662281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.