NCT04465357已完成4 期
A Multicenter, Open Label Study Assessing the Efficacy of Erenumab on Functional Impact of Migraine
Merle Diamond3 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年10月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at End of Treatment (Treatment Month 3).
研究概览
简要总结
The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine in adults.
详细描述
This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 20 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 54 participants will be enrolled to study intervention. All participants in this single-group study will complete a 4-week run-in period. After the run-in period, eligible participants will be enrolled to study intervention and enter a 12-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •willing to participate and sign informed consent;
- •ability to understand informed consent and study procedures, including able to use the electronic Daily Headache Diary;
- •in good general health based on investigator's judgment;
- •must be between 18 to 65 years of age, inclusive, at time of Visit 2;
- •have migraine with or without aura meeting the diagnostic criteria listed in the International Classification of Headache Disorders 3rd edition (ICHD-III; Appendix 5);
- •verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase reporting 4-20 migraine days and no more than 20 total headache days;
- •onset of migraine before age 50;
- •able to differentiate migraine from other primary headache types allowed in the study (e.g., tension-type headache);
- •stable history of migraine at least 3 months prior to screening with headache free periods;
- •not currently taking a migraine preventive OR has been taking a stable dose of a preventive for at least 90 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period;
- •**participants on migraine preventive should have stable headache pattern
- •must have a score of ≥ 3 on the Migraine Functional Impact Questionnaire (MFIQ) overall impact on usual activities item at screening;
- •women may be included only if they have a negative pregnancy test at screening and baseline, are sterile, or postmenopausal. Women of childbearing potential (WOCBP) whose male partners are potentially fertile (i.e., no vasectomy) must use highly effective birth control methods for the duration of the study (i.e., starting at screening). Definitions of WOCBP, sterile and postmenopausal women, male contraception, and highly effective and acceptable birth control methods are to be determined based on investigator's judgment;
- •demonstrated compliance with the electronic Daily Headache Diary during the 28-day screening/baseline phase as defined by entry of headache data on a minimum of 23 days;
- •is willing to wear activity/sleep tracker throughout the duration of the trial;
- •has a smartphone and willing to install activity tracker app on phone.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;
- •pregnant, actively trying to become pregnant, or breast-feeding;
- •history of substance abuse and/or dependence, in the opinion of the Investigator;
- •history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study;
- •suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events;
- •a psychiatric condition, in the opinion of the investigator, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study;
- •received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
- •prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
- •has failed more than 3 classes of medications for the prevention of migraine, or >6 migraine preventative medications of any type due to lack of efficacy;
- •received any investigational agents within 30 days prior to Visit 1 (6 months for any investigational biological products unless previous study blind has been broken and subject was known to have received placebo);
- •plans to participate in another clinical study at any time during this study;
- •history of medication overuse of opioids or butalbital, as defined by opioid or butalbital use ≥10 days/month in previous 12 months or during run-in period; Medication Overuse Headache (MOH) with other medication types will be allowed but must be documented;
- •unstable medication use for migraine prevention (changes in the last 3 months);
- •clinically relevant lab results at screening as determine by the investigator;
- •clinically relevant or significant ECG abnormalities as determine by the investigator, including ECG with QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) > 500 msec;
- •history of any of the following cardiovascular conditions:
- •Moderate to severe congestive heart failure (New York Heart Association class III or IV);
- •Recent (within past 12 months) cerebrovascular accident, myocardial infarction, coronary stenting;
- •Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
- •active HIV or Hepatitis C infection;
- •allergy to latex;
- •score of > 0 on question 9 on Patient Health Questionnaire (PHQ-9) at any visit;
- •have any other condition, that in the judgment of the investigator, would make the participant unsuitable for inclusion, or would interfere with the participant participating in or completing the study.
研究组 & 干预措施
Erenumab-Aooe 140 MG/ML [Aimovig]
Experimental
Participants received 140 mg/mL administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for three months (12 weeks).
干预措施: Erenumab-Aooe 140 MG/ML [Aimovig] (Drug)
结局指标
主要结局
Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at End of Treatment (Treatment Month 3).
时间窗: Baseline and Treatment Month 3
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
次要结局
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Emotional Function" Scores at Baseline and at the End of Treatment (Treatment Month 3).(Baseline and Treatment Month 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Physical Function" Domain Scores at Baseline and at the End of Treatment (Treatment Month 3).(Baseline and Treatment Month 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Usual Activities" Scores at Baseline and at the End of Treatment (Treatment Month 3).(Baseline and Treatment Month 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Social Function" Scores at Baseline and at the End of Treatment (Treatment Month 3).(Baseline and Treatment Month 3)
- Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Physical Function" Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Usual Activities" Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Emotional Function" Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Social Function" Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3.(Baseline and Treatment Months 1, 2, and 3)
- Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3(Baseline and Treatment Months 1, 2, and 3)
研究者
Merle Diamond
President, Managing Director
Diamond Headache Clinic
研究点 (3)
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