NCT00612105已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Proof-of-Concept Study to Evaluate the Efficacy of Maximally Tolerated Doses of Retigabine vs. Placebo in Reducing the Pain Associated With Post-Herpetic Neuralgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 187
- 主要终点
- Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing pain associated with post-herpetic neuralgia.
详细描述
This is a Phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs. placebo in patients with post-herpetic neuralgia. After screening, patients will enter a maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •Male or female subjects
- •18-85 years of age
- •PHN for more than 6 months after the healing of herpes zoster skin rash
- •Has a pain score at screening and randomization that qualifies
排除标准
- •Other significant pain that may potentially confound PHN pain assessment
- •Previous neurolytic or neurosurgical therapy for PHN
- •Subject has evidence of a progressive central nervous system (CNS) disease (e.g. CNS lupus, tumors, multiple sclerosis, Alzheimer's), lesion, or encephalopathy
- •Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or recent history of suicidal ideation
- •Has clinically significant abnormalities on physical examination, vital signs, ECG, or laboratory tests at the screening visit
研究组 & 干预措施
1
Experimental
Retigabine
干预措施: Retigabine (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.
时间窗: Baseline and Week 4 (Maintenance Phase-MP)
Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.
次要结局
- Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment(Baseline and Weeks 2 and 4 (Maintenance Phase - MP))
- Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)(Weeks 1, 2, 3, and 4 Maintenance Phase)
- Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)(Baseline and Weeks 1, 2, 3, and 4 (MP))
- Number of Participants Classified as Responders, With a 50% and 30% Pain Reduction From Baseline to the Last 7 Days of the Maintenance Phase(Baseline and Week 4 Maintenance Phase (MP))
- Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Medical Outcomes Study (MOS) Sleep Scale Scores(Baseline and End of Maintenance Phase (MP) (Week 4).)
- Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Sleep Quantity(Baseline and End of Maintenance Phase (MP) (Week 4).)
- Number of Participants With the Indicated Change From Baseline to the End of the Maintenance Phase in Optimal Sleep Based on the Sleep Quantity Domain of the MOS Sleep Scale(Baseline and End of Maintenance Phase (MP) (Week 4).)
- Number of Participants With the Indicated Overall Patient Global Impression of Change (PGIC)(Baseline to the end of Maintenance Phase (MP) (Week 4))
- Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) at the End of the Maintenance Phase(End of Maintenance Phase (MP) (Week 4))
- Scores on the Brief Pain Inventory-Short Form (BPI-SF) at the End of the MP for All Participants Who Completed Week-4 of the MP and Who Terminated Early During the MP(End of Maintenance Phase (MP) (Week 4))
- Scores on the Medical Outcomes Short Form-36 (SF-36) at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP(End of Maintenance Phase (MP) (Week 4))
- Scores for Reported Health Transition at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP(End of maintenance Phase (MP) (Week 4))
- Number of Participants With the Indicated Responses at Baseline to the Question: "How Painful Was the Affected Side Compared to the Opposite Side?" in an Assessment of Tactile Allodynia(Baseline Phase (Day -7 to Randomization Day 0))
- Number of Participants With the Indicated Responses at Baseline to the Questions of "Is it Cool?" and "Is it Painful?" in an Assessment of Cold Threshold and Allodynia(Timeframe: Baseline Phase (Day -7 to Randomization Day 0))
- Number of Participants With the Indicated Responses at the End of the MP to the Question: "How Painful Was the Affected Side Compared to the Opposite Side?" in an Assessment of Tactile Allodynia(End of Maintenance Phase (MP) (Week 4))
- Number of Participants With the Indicated Responses at the End of the MP to the Questions of "Is it Cool?" and "Is it Painful?" in an Assessment of Cold Threshold and Allodynia(End of Maintenance Phase (MP) (Week 4))
- Number of Subjects With the Indicated Responses at Baseline to the Questions: "How Sharp Was the Affected Side Compared to the Opposite Side?" and "How Painfule Was the Affected Side Compared to the Opposite Side?" in an Assessment of Hyperalgesia(Baseline Phase (Day -7 to Randomization Day 0))
- Number of Participants With Indicated Responses at the End of the MP to the Questions: "How Sharp Was the Affected Side Compared to the Opposite Side?" and "How Painful Was the Affected Side Compared to the Opposite Side?" in an Assessment of Hyperalgesia(End of Maintenance Phase (MP) (Week 4))
- Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype "Irritable Nociceptors"(Baseline and Week 4 Maintenance Phase (MP))
- Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype"Deafferentation Type 1 (D Type 1)"(Baseline and Week 4 Maintenance Phase (MP))
- Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype "Deafferentation Type 2 (D Type 2)"(Baseline and Week 4 Maintenance phase (MP))
- Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype "Unclassifiable"(Baseline and Week 4 Maintenance Phase (MP))
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