Postherpetic Neuralgia
Conditions
Brief summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.
Interventions
DRUGPlacebo
LX9211 matching-placebo, tablets will be administered orally.
DRUGLX9211
LX9211 tablets will be administered orally.
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Czechia, Poland, United States
Contacts
STUDY_DIRECTORSuma Gopinathan, PhD
Lexicon Pharmaceuticals
Participant flow
Recruitment details
Participants took part in the study at multiple investigative sites from 10 Dec 2020 to 28 Dec 2022.
Pre-assignment details
Following a 2-week single blind Run-in period, a total of 79 participants were randomized and treated in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 76 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 38 | 0 / 38 | 0 / 31 |
| other Total, other adverse events | 6 / 41 | 24 / 38 | 2 / 38 | 1 / 31 |
| serious Total, serious adverse events | 0 / 41 | 0 / 38 | 0 / 38 | 0 / 31 |
Outcome results
None listed