EUCTR2018-004337-32-GB进行中（未招募）1 期
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ATOGEPANT FOR THE PREVENTION OF CHRONIC MIGRAINE (PROGRESS) - Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent and participant privacy information (eg, Written Authorization for Use and Release of Health and Research Study Information) obtained from the participant prior to initiation of any study-specific procedures
- •2. Male or female participants ages 18 to 80 years, inclusive, at Visit 1
- •3. At least a 1-year history of CM consistent with a diagnosis according to the ICHD 3, 2018
- •4. Age of the participant at the time of migraine onset < 50 years
- •5. Confirmation of headache/migraine headache day frequency as follows:
- •a. History of, on average, = 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
- •b. = 15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
- •c. = 8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
- •6. Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator’s judgment
- •7. Participants must be using a medically acceptable and effective method of birth control during the course of the entire study, as defined in Section 4.4.3 of the study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 728
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1.Difficulty distinguishing migraine headaches from tension-type or other headaches
- •2.Has a history of migraine, accompanied by diplopia or decreased level of consciousness or retinal migraine
- •3.Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
- •4.History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
- •5.Currently taking more than 1 medication with demonstrated efficacy for the prevention of migraine OR participants who are taking 1 migraine prevention medication, but in the opinion of the investigator:
- •the dose has not been stable and/or the medication has not been well-tolerated for at least 12 weeks prior to Visit 1
- •the participant is not willing or able to maintain taking this medication at a stable dose and dosage regimen throughout the study
- •6.Requirement for any medication, diet, or non-pharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment
- •7.Usage of opioids and/or barbiturates > 4 days/month in the 3 months prior to Visit 1 per investigator’s judgment or during the baseline period
- •8.Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating
- •9.An ECG with clinically significant abnormalities at screening
- •10.QTcF > 450 msec for males and QTcF > 470 msec for females at Visit 1 on the final central vendor ECG report
- •11.Clinically significant cardiovascular or cerebrovascular disease per the investigator’s opinion
- •12.Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2
- •13.Clinically significant laboratory values OR any of the following laboratory values at Visit 1
- •ALT or AST > 1 x ULN OR
- •total bilirubin > 1 x ULN (except diagnosis of Gilbert’s disease) OR
- •serum albumin < 2.8 g/dL
- •14.Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease
- •If there is a history of such a disease, but the condition has been stable for more than 1 year prior to Visit 1, and is judged by the investigator as not likely to interfere with study participation
- •Participants on dialysis for renal failure are excluded
- •15.History of acute hepatitis within 6 months of screening; or chronic hepatitis, or a positive result on anti hepatitis A IgM antibody, hepatitis B surface antigen, anti–hepatitis C antibody, or anti-hepatitis E IgM antibody testing
- •16.In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy or significant neurological disorders other than migraine
- •17.Any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
- •18.Significant risk of self-harm based on clinical interview and responses on the C-SSRS, or of harm to others; participants must be excluded if they report suicidal ideation with intent in the past 6 months or report suicidal behavior in the 6 months prior to Visit 1 or Visit 2 assessments
- •19.History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- •20.History of any gastrointestinal prior procedures or gastrointestinal conditions that may affect the absorp
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