Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)
研究概览
简要总结
This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg once daily (QD) compared with placebo on the reduction of pain severity in participants with central neuropathic pain due to Multiple Sclerosis.
详细描述
Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Participants who screen successfully (Study Period I) will be randomized in a 1:1 fashion to duloxetine 60 mg QD or placebo. Starting with Study Period II, participants will be treated in a double-blind manner for 6 weeks. Participants who complete the 6-week, double-blind period will have the opportunity to participate in a 12-week, open-label, flexible-dose portion of the study (Study Period III). Study Period IV is a taper phase designed to reduce the occurrence of discontinuation adverse events. Participants may enter Study Period IV at any time after Visit 3.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have central neuropathic pain due to multiple sclerosis (MS) based on the disease diagnostic criteria
- •Adult males or females
- •Have a score of 4 or greater on the daily 24-hour average pain score
- •Females must test negative for pregnancy at study entry
- •Complete the daily diaries for at least 70% of the days of the study
- •Participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study Disease Diagnostic Criteria:
- •Diagnosis of MS at least 1 year prior to study entry
- •No MS flares or change in disease treatment for the 3 months prior to study entry
- •Daily pain due to MS for a minimum of 3 months prior to study entry
排除标准
- •Are currently in a clinical trial of MS disease-modifying therapy
- •Have pain that cannot be clearly differentiated from causes other than MS
- •Any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
- •History of substance abuse or dependence
- •Are pregnant or breast-feeding
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Duloxetine
干预措施: Duloxetine Hydrochloride (HCI) (Drug)
结局指标
主要结局
Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)
时间窗: Baseline, 6 weeks
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.
次要结局
- Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)(Baseline, 6 weeks)
- Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks(6 weeks)
- Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)(Baseline, 6 weeks)
- Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6(6 weeks)
- Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18(Baseline (end of acute phase/Week 6), Endpoint (Week 18))
- Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)(Baseline (6 weeks), Endpoint (18 weeks))
- Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)(Baseline (6 weeks), Endpoint (18 weeks))
- Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18(18 weeks)
- Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)(Baseline (6 weeks) through Endpoint (18 weeks))
- Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)(Baseline, 6 weeks)
- Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)(Baseline, 6 weeks)
- Number of Participants Who Discontinued During the Acute Phase (by Week 6)(Baseline through 6 weeks)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase(Baseline through 6 weeks)
- Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase(Baseline through 6 weeks)
- Change From Baseline in Blood Pressure at Week 6 (Acute Phase)(Baseline, 6 weeks)
- Change From Baseline in Pulse Rate at Week 6 (Acute Phase)(Baseline, 6 weeks)
- Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)(Baseline, 6 weeks)
- Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)(Baseline, 6 weeks)
- Change From Baseline in Weight at Week 6 (Acute Phase)(Baseline, 6 weeks)
- Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks(18 weeks)
- Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)(Baseline (6 weeks), Endpoint (18 weeks))
- Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)(Baseline (6 weeks) through Endpoint (18 weeks))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase(Baseline (6 weeks) through Endpoint (18 weeks))
- Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase(Baseline (6 weeks) through Endpoint (18 weeks))
- Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)(Baseline (6 weeks), Endpoint (18 weeks))
- Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)(Baseline (6 weeks), endpoint (18 weeks))
- Change From Baseline in Weight at Week 18 (Open-label Extension Phase)(Baseline (6 weeks), Endpoint (18 weeks))