A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX9211 in the Treatment of Postherpetic Neuralgia (RELIEF-PHN1)
概览
- 阶段
- 2 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Postherpetic Neuralgia
- 发起方
- Lexicon Pharmaceuticals
- 入组人数
- 79
- 试验地点
- 32
- 主要终点
- Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo
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.
干预措施: LX9211
结局指标
主要结局
Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS)
时间窗: 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.
次要结局
- Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6(Baseline to Week 6)
- Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6(Baseline to Week 6)
- Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6(Baseline to Week 6)
- 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)
- 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)
- Patient Global Impression of Change (PGIC) at Week 6(Baseline to Week 6)
- 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)
- 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))