Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine Who Have Previously Failed 1 or More Migraine Preventive Treatments.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP
研究概览
简要总结
To evaluate the effect of erenumab compared to placebo on disability in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.
详细描述
Migraine prevention continues to be an area of large, unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) has an important role in the pathophysiology of migraine. Erenumab-aooe is a fully human monoclonal antibody that targets the CGRP receptor, and interrupts its downstream effects. Erenumab has been approved for the preventive treatment of migraine in adults. The present study is a Phase IV trial that will assess the effect of erenumab on disability and work productivity in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 18 years of age upon entry into screening.
- •Documented history of migraine with or without aura according to the IHS ICHD-III for greater than or equal to 12 months
- •Has EM defined as history of greater than or equal to 4 and less than 15 migraine days and less than 15 headache days per month on average during the 3 months prior to initial screening
- •Employed greater than or equal to 20 hours/week upon entry into initial screening, stable for at least 3 months in the same job and has not specified willful termination of employment throughout the duration of the study. Employment is defined by work outside the home, self-employed, or works from home
- •Has greater than or equal to 4 hours of lost productive time due to headache/migraine and/or related symptoms in the past month prior to initial screening as determined by subject
- •Has total disability score of greater than 10 as assessed by MIDAS (3-month recall) at initial screening
- •History of treatment failure with at least 1 preventive treatment category for migraine
排除标准
- •Older than 50 years of age at migraine onset
- •History of cluster headache, hemiplegic migraine, or other trigeminal autonomic cephalalgia.
- •Taken an opioid and/or opioid-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
- •Taken a butalbital and/or butalbital-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
- •Change in the regimen of current migraine preventive treatment or a concomitant medication that may have migraine prevention effects during baseline
- •Taken an opioid and/or opioid-containing analgesic ≥ 4 days during baseline for any indication.
- •Taken a butalbital and/or butalbital-containing analgesic ≥ 4 days during baseline for any indication.
- •Previously treated with any agent (monoclonal antibody or small molecule) targeting the CGRP pathway (ligand or receptor) in preventive settings
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo.
干预措施: Placebo (Drug)
Erenumab
After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo.
干预措施: Erenumab (Drug)
结局指标
主要结局
Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP
时间窗: Baseline and Months 1 to 6
The modified MIDAS Questionnaire is a 5-item questionnaire that measures headache-related disability as lost time from paid work or school, housework, and non-work (family, social, and leisure) activities. Participants provided the number of productive days lost or productivity reduced by half or more over the past month due to headache (item score range from 0 to 31). Productive days lost counted in items 1 and 3 were not included for items 2 and 4, respectively. The 5 item scores were summed to calculate the MIDAS total score (range from 0 to 93). The change from baseline was calculated by subtracting the baseline total score from the total score calculated each month. The change from baseline values for Months 1 to 6 were then summed to calculate the sum of monthly changes from baseline (range from -558 to 558). A negative sum of changes from baseline indicated a better outcome.
次要结局
- Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP(Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP)
- Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP(Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP)
- Change From Baseline in Mean MFIQ Usual Activities Domain Score Over Months 4, 5, and 6 of the 6-month DBTP(Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP)
- Change From Baseline in Mean MFIQ Physical Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP(Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP)
- Change From Baseline in Mean MFIQ Social Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP(Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP)