NCT03700320已完成3 期
A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 744
- 试验地点
- 101
- 主要终点
- Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
- •Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
- •Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
- •At least a 1-year history of migraine with or without aura consistent with a diagnosis
- •Age of the participant at the time of migraine onset < 50 years
- •History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1
排除标准
- •Difficulty distinguishing migraine headaches from tension-type or other headaches
- •Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
- •Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
- •≥ 15 headache days per month on average across the 3 months prior to Visit 1
- •Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
- •Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test
- •Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
- •Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit
- •Vital sign measurements that exceed these limits may be repeated only once.
- •At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
- •History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.
研究组 & 干预措施
Oral SOC Migraine Preventive Medication
Active Comparator
Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
干预措施: Standard of Care (SOC) Migraine Preventive Medication (Drug)
Atogepant 60 mg
Experimental
Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
干预措施: Atogepant (Drug)
结局指标
主要结局
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
时间窗: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.
次要结局
- Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator(From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up)
- Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator(Up to Week 52)
- Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator(From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up))
- Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior(Up to Week 52)
研究者
研究点 (101)
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