A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Tolerability Titration Study To Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)
研究概览
简要总结
The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (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
- •To be included, patients must meet the following:
- •Provide written informed consent, prior to entering the study or undergoing any study procedures.
- •Male and female patients ≥18 years of age. Females should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception. Acceptable contraception includes: abstinence, a barrier method plus spermicide, or intrauterine device [IUD]. Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD). Contraceptive use must start at least 1 month before Visit 1, be practiced throughout the entire study period, and continue for 1 month after the end of the study. They must also have a negative serum beta-human chorionic gonadotropin (β-hCG) at Visit 1, and a negative urine pregnancy test at Baseline Visit
- •PHN of at least 6 months duration; the onset of PHN is defined as the time from healing of herpes zoster skin lesions.
- •Pain over the past 6 months, and not in a clinically identifiable improving or worsening trend, based on medical history.
- •Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Visit 1 and Baseline (Visit 2 prior to randomization).
- •Have completed the patient diary for at least 6 of the 7 days prior to Visit 2 (Baseline).
- •Average daily pain score of ≥ 4, on 11-point Likert scale during the 7 days prior to randomization [from the diaries].
- •Reliable and willing and able to cooperate with all study procedures, including the following examples:
- •Accurately entering the diary on a daily basis
- •Returning for study visits on the required dates
- •Accurately and reliably reporting symptoms (including treatment-emergent signs and symptoms)
- •Taking study drug as required by protocol
- •Be on stable analgesic treatment (same medication(s)) or stable nonpharmacological pain treatment for at least 4 weeks prior to Visit 1 and remain on this stable treatment throughout the study. Nonpharmacologic pain treatment includes the following:
- •relaxation/hypnosis
- •physical or occupational therapy
- •mental-health counseling
- •acupuncture
- •injections
- •blocks, etc.
- •Episodic or periodic pharmacologic treatments such as monthly injections for treatment of pain (eg, local anesthetics) will not be permitted.
- •Up to 4 g of acetaminophen/day is permitted as rescue medication, as needed, during the trial.
排除标准
- •Patients with any of the following are to be excluded:
- •Any condition that could interfere with the conduct of the trial or confound efficacy evaluations including the following examples: pain or neuropathy from another cause (including painful diabetic neuropathy), such as central pain, radiculopathy, painful arthritis, etc.
- •Motivation by secondary gain, or where there is a negative-incentive to achieving pain and functional relief (eg, litigation). This will be determined from the medical history and is at the discretion of the investigator.
- •Inability to cooperate with protocol, for any reason.
- •Clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine, or immunologic, including patients with any of the following broad disease categories:
- •Systemic infections (eg, human immunodeficiency virus [HIV], hepatitis, tuberculosis [TB], syphilis); lack of appropriate medical history of these conditions is acceptable,
- •History of past (within the past 12 months) or present drug or alcohol abuse as per the Diagnostic and Statistical Manual - 4th Edition (DSM IV) criteria,
- •History of acute coronary syndrome within the past 12 months,
- •Active cancer within the previous 5 years (the exception is fully treated, non-melanoma skin cancer such as basal cell carcinoma),
- •Systemic chemotherapy or immunotherapy within the past 5 years,
- •History of major depression, bipolar disease, psychosis or suicidal ideation or attempts within the past 5 years,
- •History of major systemic allergy such as anaphylactoid reactions or Stevens-Johnson syndrome (however, patients with limited allergies such as contact dermatitis or minor allergy to penicillin are acceptable).
- •Any of the following laboratory abnormalities at Visit 1:
- •Clinically significant ECG abnormality, including prolonged QTc (defined as QTcB > 450 msec),
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN),
- •Clinically significant abnormal white blood cell (WBC), absolute neutrophil, or platelet count values,
- •Any other clinically significant laboratory value.
- •Exposure to an investigational drug within the 30 days prior to Visit 1 or exposure ever to perampanel.
- •Females who are pregnant, lactating, or planning to become pregnant during the study.
- •Use of any medication known to be a strong inducer of CYP3A4 activity within 4 weeks prior to Visit 1; use of CYP3A4 inducers is prohibited for the entire study duration.
研究组 & 干预措施
Placebo Cohort 1
干预措施: Placebo (Drug)
Perampanel Cohort 1, 3-week Titration
干预措施: E2007 (perampanel) (Drug)
Placebo Cohort 2
干预措施: Placebo (Drug)
Perampanel Cohort 2, 1-week Titration
干预措施: E2007 (perampanel) (Drug)
Perampanel Cohort 2, 2- Week Titration
干预措施: E2007 (perampanel) (Drug)
结局指标
主要结局
Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)
时间窗: Baseline and Week 15
Average pain scores are based on pain intensity (11-point Likert-type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Responder Rate: Subjects With at Least 30 Percent Reduction in Pain
时间窗: Baseline and Week 15
A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Responder Rate: Subjects With at Least 50 Percent Reduction in Pain
时间窗: Baseline and Week 15
A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Change From Baseline in Average Pain Scores by Week
时间窗: Week 1 through Week 16
Change from baseline in average pain scores by week based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.
次要结局
- Change From Baseline to Week 15/EOT in Average Sleep Interference Scores(Baseline and Week 15)
- Patient Global Impression of Change (PGIC) at Week 15/EOT(Week 15)
- Clinician Global Impression of Change (CGIC) at Week 15/EOT(Week 15)
- Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)(Baseline and Week 15)
- Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)(Baseline and Week 15)
- Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF)(Week 15)