A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients With Postherpetic Neuralgia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 77
- 主要终点
- Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures
研究概览
简要总结
This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous.
- •Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2, inclusive, at the screening visit.
- •If the patient is a woman and is fertile, the patient is not pregnant and has negative pregnancy tests at both the screening and randomization visits, and agrees to use an acceptable method of contraception for the duration of the study, including follow-up.
- •If the patient is a man and is capable of producing offspring, the patient must agree to use an acceptable method of contraception, unless the partner cannot become pregnant for the duration of the study, including follow-up.
- •Patient must sign the written Informed Consent Form (ICF) for the study and be willing to comply with all study procedures and restrictions.
- •Patient must be judged by the investigator to be medically healthy (except for PHN) and able to participate in the study
- •Other criteria apply, please contact the investigator for more information
排除标准
- •Patient has any other severe pain that might confound assessment or self-evaluation of pain due to PHN.
- •Patient has PHN affecting the face (trigeminal nerve distribution).
- •Patient has a history, in the judgment of the investigator, of inadequate response to more than 3 adequate courses of treatment with other medications used to treat neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).
- •Patient is taking oral analgesics (either opioid or non-opioid) or is receiving topical therapy such as the 5% topical lidocaine patch for the treatment of pain and is unwilling or unable to complete a washout period during which the patient will discontinue analgesic therapy or topical pain therapy.
- •Patient has been treated with topical capsaicin at any time in the past 6 months for neuropathic pain.
- •Patient has a history of fibromyalgia.
- •Other criteria apply, please contact the investigator for more information
研究组 & 干预措施
TV-45070 4%
TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
干预措施: TV-45070 (Drug)
TV-45070 8%
TV-45070 ointment in a 8% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
干预措施: TV-45070 (Drug)
Placebo
Placebo ointment applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures
时间窗: Baseline (day -7 to day -1), Week 4 (day 22 to day 28)
The primary efficacy endpoint was the change from baseline to week 4 in the weekly average of the daily average NRS scores. The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. At least 1 of the 2 daily scores had to be recorded (non-missing) or the daily average was considered missing. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.
次要结局
- Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Morning Using a Mixed Model for Repeated Measures(Baseline (day -7 to day -1), Week 4 (day 22 to day 28))
- Percentage of Participants With >=30% and >=50% Improvement From Baseline in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores at Week 4 Using a Mixed Model for Repeated Measures(Baseline (day -7 to day -1), Week 4 (day 22 to day 28))
- Change From Baseline to Weeks 2 and 4 in the Neuropathic Pain Symptom Inventory (NPSI) Total Score Using a Mixed Model for Repeated Measures (MMRM)(Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29))
- Change From Baseline to Weeks 2 and 4 in the Daily Sleep Interference Scale (DSIS) Using a Mixed Model for Repeated Measures(Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29))
- Kaplan-Meier Estimates for First Time to Reach 30% or More Sustained Improvement in Weekly Average of the Daily Average NRS Pain Scores(Baseline (days -7 to -1), Week 1 (days 1-7), Week 2 (day 8-14), Week 3 (days 15-21), Week 4 (days 22-29))
- Participants With Treatment-Emergent Adverse Events(day 1 up to day 57)
- Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures(Baseline (day -7 to day -1), Week 4 (day 22 to day 28))
- Change From Baseline to Week 4 in the Weekly Average of the Worst Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures(Baseline (day -7 to day -1), Week 4 (day 22 to day 28))
- Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)(Weeks 2 (day 15) and Week 4 (day 29))
- Change From Baseline to Week 4 in the Neuropathic Pain Impact on Quality of Life (NePIQoL) Total Score(Baseline (day 1), Week 4 (day 29))
- Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Brush-Evoked Allodynia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM)(Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29))
- Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Punctate-Evoked Hyperalgesia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM)(Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29))