Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
- Registration Number
- NCT04662281
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Following a 2-week Single-blind Run-in period, participants will receive 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. LX9211 LX9211 Following a 2-week Single-blind Run-in period, participants will receive a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
- Primary Outcome Measures
Name Time Method Change from Baseline in Average Daily Pain Score (ADPS) Day 1 to Week 6 The change from Baseline (Week 2) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (0 \[No Pain\] to 10 \[Pain as bad as you can imagine\])
- Secondary Outcome Measures
Name Time Method ≥30 percent reduction in pain intensity Day 1 to Week 6 Proportion of patients with ≥30% reduction in pain intensity
≥50 percent reduction in pain intensity Day 1 to Week 6 Proportion of patients with ≥50% reduction in pain intensity
Safety: number of AEs reported Day 1 to Week 6 Number of Adverse Events
Trial Locations
- Locations (14)
Lexicon Investigational Site (138)
🇨🇿Choceň, Czechia
Lexicon Investigational Site (133)
🇵🇱Warsaw, Poland
Lexicon Investigational Site (141)
🇨🇿Praha, Czechia
Lexicon Investigational Site
🇺🇸Kenosha, Wisconsin, United States
Lexicon Investigational Site (137)
🇨🇿Praha, Czechia
Lexicon Investigational Site (135)
🇨🇿Praha, Czechia
Lexicon Investigational Site (147)
🇺🇸Marietta, Georgia, United States
Lexicon Investigational Site (148)
🇺🇸Cary, North Carolina, United States
Lexicon Investigational Site (140)
🇨🇿Pardubice, Czechia
Lexicon Investigational Site (136)
🇨🇿Praha, Czechia
Lexicon Investigational Site (128)
🇵🇱Katowice, Poland
Lexicon Investigational Site (130)
🇵🇱Katowice, Poland
Lexicon Investigational Site (134)
🇵🇱Lublin, Poland
Lexicon Investigational Site (113)
🇺🇸Miami, Florida, United States