2023-506029-12-00招募中3 期
Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 755
- 试验地点
- 80
- 主要终点
- Pain freedom (defined as a reduction in headache severity from moderate/severe at baseline [predose] to no pain) at 2 hours after the DB dose for the first attack
研究概览
简要总结
The primary objective of the trial is to evaluate the efficacy of a single dose of atogepant compared to placebo for the acute treatment of a single migraine attack. The first migraine attack during the DB treatment period will be used to assess efficacy of a single attack.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open Label Treatment Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.
- •History of migraines lasting between 4 to 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom.
- •History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment.
- •Female subjects who are not pregnant or breastfeeding, and are not planning to become pregnant or donate eggs during the study and for approximately 30 days after the last dose of study drug.
- •Female subjects (or individuals) of childbearing potential must have a negative serum pregnancy test at Visit 1/Screening and a negative urine pregnancy test at Visit 2/Randomization. Subjects with a borderline serum pregnancy test at Visit 1/Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥3 days later to document continued lack of a positive result (unless prohibited by local requirements). Subjects with a urine pregnancy test at Visit 2/Randomization that is borderline or ambiguous must have a serum pregnancy test. In such cases, the subjects must be excluded from participation if the serum pregnancy result is positive.
- •Female subjects (or individuals) of childbearing potential must practice at least 1 protocol-specified method of birth control, from 30 days prior to Visit 2/Randomization until 30 days after the last dose of study drug. Female subjects of nonchildbearing potential do not need to use birth control.
- •Has used prescription or nonprescription medication for the acute treatment of migraine in the past.
- •Oral migraine medications used for prophylaxis on-label or off-label (e.g., topiramate, amitriptyline, beta blockers, flunarizine, venlafaxine, etc.), and injectable onabotulinum toxin A and other therapies used for migraine prevention are permitted provided that the treatment is stable for at least 3 months prior to Visit 2/Randomization and continues without change in dose throughout the study.
- •Subjects enrolling in the Triptan-Unsuitable substudy (applicable only after completion of enrollment in the main study) must meet all the inclusion criteria listed for the main study and must not meet any of the exclusion criteria listed for the main study. In addition, subjects must meet the following inclusion criterion: Subject must be ""triptan-unsuitable"" defined as meeting 1 of the 2 following criteria: -has a contraindication to triptans based upon local label and investigator judgment, irrespective of prior triptan use OR meets the following triptan failure definition for ≥2 different triptans: Currently uses a triptan or has used a triptan in the past and has not achieved pain relief (defined as the reduction of a moderate/severe migraine headache to a mild headache or no headache) at 2 hours postdose in ≥2 out of 4 attacks based upon subject interview and investigator judgment OR -Used a triptan in the past but no longer uses a triptan due to AEs based upon subject interview and investigator judgment.
- •Ability and willingness to read, understand, and complete study questionnaires and eDiary.
- •Aged 18 to 75 years, inclusive, at Visit 1/Screening (subjects must also meet the legal age of majority per local law).
- •History of migraine (with or without aura) according to the ICHD-3 for ≥12 months prior to Visit 1/Screening.
- •Migraine onset before the age of 50.
排除标准
- •Subject has difficulty in distinguishing migraine headache from tension-type or other headaches per the investigator's judgment.
- •Positive result on the urine drug screen at Visit 1/Screening unless explained by allowed concomitant medication use (e.g., opioids prescribed for migraine pain, use of benzodiazepines for insomnia).
- •Positive result on the hepatitis B surface antigen or the anti-hepatitis C antibody testing at Visit 1/Screening.
- •Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy and other significant neurological disorders other than migraine per investigator judgment.
- •Presence of chronic, nonheadache pain condition requiring daily pain medication.
- •Clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, psychiatric, or neurologic disease. -If there is a history of such disease but the condition has been stable for more than 6 months prior to Visit 1/Screening and is judged by the investigator as not likely to interfere with the subject's participation in the study, the subject may be included. -Subjects on dialysis for renal failure are not allowed to participate in the study.
- •Significant risk of self-harm, based on clinical interview or responses on the C-SSRS, or harm to others per the opinion of the investigator; subjects must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the last 6 months prior to Visit 1/Screening or Visit 2/Randomization.
- •History of malignancy in the 5 years prior to Visit 1/Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- •History of any prior gastrointestinal conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of study drug. -Subjects with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed may participate.
- •History of acute hepatitis within 6 months of Visit 1/Screening or any history of chronic liver disease (including nonalcoholic fatty liver disease, viral chronic hepatitis, and cirrhosis).
- •History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist.
- •History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-
- •(Note: subjects with a diagnosis of chronic migraine who, in the opinion of the investigator, have fewer than 15 headache days per month due to concomitant prophylactic treatment are allowed to participate in the study).
- •Subject is an employee or immediate family member (parents, spouses, siblings, or children) of one of the investigators, study staff, or AbbVie.
- •Subject has condition or situation, which the investigator feels will compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.
- •Subject has taken medication for acute treatment of headache (including acetaminophen, NSAIDs, triptans, ditans, ergotamine, opioids, gepants, or combination analgesics) 10 or more days per month in any of the 3 months prior to Visit 2/Randomization.
- •Subject has taken strong CYP3A4 inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodone, and HIV protease inhibitors within 30 days or 5 half-lives of the drug (whichever is longer) prior to Visit 2/Randomization.
- •Subject has taken strong or moderate CYP3A4 inducers, including but not limited to barbiturates (e.g., phenobarbital and primidone), efavirenz, carbamazepine, phenytoin, rifampin, and St John's wort within 30 days or 5 half-lives of the drug (whichever is longer) prior to Visit 2/Randomization.
- •Subject has taken strong OATP1B1/OATP1B3 inhibitors (e.g., cyclosporine, telmisartan) within 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit 2/Randomization.
- •Subject has taken drugs with narrow therapeutic margins with theoretical potential for CYP drug interactions (e.g., warfarin) within 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit 2/Randomization.
- •Subject has been exposed to any gepant within 30 days prior to Visit 2/Randomization.
- •Subject has been exposed to injectable monoclonal antibodies blocking the CGRP pathway within 6 months prior to Visit 2/Randomization.
- •History of clinically significant drug or alcohol abuse or dependency in the 12 months prior to Visit 1/Screening, or subject had concomitant cannabis or ingested CBD oil use, either recreational or for medical reasons, within 30 days prior to Visit 2/Randomization.
- •Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), and painful cranial neuropathy as defined by ICHD-
- •Subject has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Visit 2/Randomization or is currently enrolled in another clinical study or was previously enrolled in this study.
- •Subject has been treated with oral herbal medicine including, but not limited to, traditional Chinese medicine within 30 days or 5 half-lives (whichever is longer) prior to Visit 2/Randomization.
- •Subject required hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening.
- •ECG with clinically significant abnormalities at Visit 1/Screening, as determined by the investigator.
- •QTcF > 450 msec for males or QTcF > 470 msec for females at Visit 1/Screening based on the report of the central reviewer.
- •Hypertension defined as sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg at Visit 1/Screening or Visit 2/Randomization. Blood pressure measurements that exceed these limits may be repeated only once.
- •Clinically significant abnormalities in the physical examination as determined by the investigator.
- •Clinically significant laboratory abnormalities as determined by the investigator, or laboratory values meeting any of the following criteria at Visit 1/Screening: ALT or AST > 1 × ULN; Total bilirubin > 1 × ULN (except for subjects with a diagnosis of Gilbert's disease); Serum albumin < 2.8 g/dL [4.06 µmol/L]
结局指标
主要结局
Pain freedom (defined as a reduction in headache severity from moderate/severe at baseline [predose] to no pain) at 2 hours after the DB dose for the first attack
Pain freedom (defined as a reduction in headache severity from moderate/severe at baseline [predose] to no pain) at 2 hours after the DB dose for the first attack
次要结局
- Absence of the MBS at 2 hours after the DB dose for the first attack (coprimary endpoint for China)
- Pain relief (defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache) at 2 hours after the DB dose for the first attack
- Sustained pain relief from 2 to 24 hours (defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack
- Sustained pain relief from 2 to 48 hours after the DB dose for the first attack
- Use of rescue medication within 24 hours after the DB dose for the first attack
- Ability to function normally at 2 hours after the DB dose for the first attack
- Sustained pain freedom from 2 to 24 hours (defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack
- Sustained pain freedom from 2 to 48 hours after the DB dose for the first attack
- Absence of photophobia at 2 hours after the DB dose for the first attack
- Absence of phonophobia at 2 hours after the DB dose for the first attack
- Pain freedom at 8 hours after the DB dose for the first attack
- Ability to function normally 8 hours after the DB dose for the first attack
- Pain relief at 1 hour after the DB dose for the first attack
- Absence of nausea at 2 hours after the DB dose for the first attack
- Pain relief at 30 minutes after the DB dose for the first attack
- Ability to function normally at 1 hour after the DB dose for the first attack
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (80)
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