NCT00785577已完成2 期
A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects With Painful Diabetic Neuropathy.
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
- 273
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks
研究概览
简要总结
The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have pain due to peripheral neuropathy based on disease diagnostic criteria: must have Type 1 or Type 2 diabetes mellitus, pain must being in the feet, with relatively symmetrical onset, daily pain must be present for at least 6 months, and diagnosis must be confirmed by a score of at least 3 on Part B of the Michigan Neuropathy Screening Instrument.
- •Have stable glycemic control, and glycated hemoglobin (HbA1c) less than or equal to 10%
- •Mean score of at least 4 on the 24-hour average page severity assessment from (from daily diary) Visits 2 to
- •Fully completed daily diaries for at least 70% of the days between Visit 2 and
- •Women must test negative for a serum pregnancy test at Visit 1, and must agree to use medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of study drug.
- •Are competent and able to freely give own informed consent.
- •Have an educational level and degree of understanding such that they can communicate intelligible with the investigator and study coordinator.
- •Have been judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
排除标准
- •Have historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy.
- •Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of diabetic neuropathy pain.
- •Have had treatment with any centrally active neuroleptic drug within 30 days of visit
- •Have had intolerance to pregabalin or have frequent and/or severe allergic reactions with multiple medications.
- •Have current or previous (within the past 1 year) Axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria, as determined by the investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- •Have a serious of unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
- •Have alanine aminotransaminase > 2 times upper limit of normal at Visit 1, based on reference ranges of central lab.
- •Have prior renal transplant, current renal dialysis, or serum creatinine laboratory values > 1.5 times upper limit of normal, based on reference ranges of the central lab at Visit
- •Have a diagnosis or history of glaucoma.
- •Are taking excluded medication that cannot be stopped and washed out prior to Visit
- •Have history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- •Are judged clinically by the investigator to be at suicidal risk in the opinion of the investigator based upon clinical interview and the Columbia Suicide-Severity Rating Scale.
- •Have a positive urine drug screen for any substance of abuse or excluded medication.
- •Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject (daily diary).
- •Are pregnant or breast-feeding.
- •Are investigator site personnel directly affiliated with this study and/or their immediate families.
- •Are Lilly employees.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Have a history of recurrent seizures other than febrile seizures.
- •Have a history of severe gastroparesis.
研究组 & 干预措施
Placebo
Placebo Comparator
LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules thrice daily (TID) po for 6 weeks
干预措施: Placebo (Drug)
Pregabalin
Active Comparator
Pregabalin thrice daily (TID) oral for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
LY545694 placebo BID po for 5 weeks
干预措施: Pregabalin (Drug)
LY545694 21 mg
Experimental
LY545694 21 milligrams (mg) BID po for 1 week
Pregabalin placebo TID po for 6 weeks
干预措施: LY545694 21 mg (Drug)
LY545694 49 mg
Experimental
LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
Pregabalin placebo TID po for 6 weeks
干预措施: LY545694 49 mg (Drug)
LY545694 105 mg
Experimental
LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
Pregabalin placebo TID po for 6 weeks
干预措施: LY545694 105 mg (Drug)
结局指标
主要结局
Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks
时间窗: Baseline, 5 weeks
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
次要结局
- Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score(Baseline, 5 weeks)
- Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase(Baseline through 6 weeks)
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks(Baseline, 5 weeks)
- Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score(Baseline through 5 weeks)
- Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks(Week 5)
- Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks(Baseline, 5 weeks)
- Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values(Baseline through 5 weeks)
- Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks(Baseline, 5 weeks)
- Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks(Baseline, 5 weeks)
- Time to Response(Baseline through 5 weeks)
- Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score(Baseline, 5 weeks)
- Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks(Week 5)
- Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks(Baseline, 5 weeks)
- Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas(Baseline through 5 weeks)
- Percentage of Participants With Reported Hypoglycemic Events(Baseline through 5 weeks)
- Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)(Baseline through 5 weeks)
- Number of Participants With Suicidal Behaviors and Ideations(Baseline through week 5)
- Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)(Baseline through 5 weeks)
研究者
研究点 (1)
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