A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 16
- 主要终点
- Percentage of Participants Who Discontinued Due to Adverse Event
研究概览
简要总结
The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age
- •Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.
排除标准
- •Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- •Current use or prior exposure to galcanezumab or another CGRP antibody.
- •Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
- •History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
研究组 & 干预措施
Galcanezumab 120 mg
Galcanezumab 240mg given as loading dose at first dosing visit followed by 120 mg given by subcutaneous (SC) injection once a month for up to 11 months by auto injector or pre-filled syringe.
干预措施: Galcanezumab (Drug)
Galcanezumab 240 mg
Galcanezumab 240 mg given by SC injection once a month for up to 12 months by auto injector or pre-filled syringe.
干预措施: Galcanezumab (Drug)
结局指标
主要结局
Percentage of Participants Who Discontinued Due to Adverse Event
时间窗: Baseline through Month 12
Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and 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 summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section.
次要结局
- Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1(Baseline, Month 1 through Month 12)
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab(Baseline through Month 12)
- Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab(Month 1 through Month 12)
- Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days(Baseline, Month 1 through Month 12)
- Serum Concentrations of Galcanezumab(Month 12)
- Overall Mean Change From Baseline in the Number of Headache Days(Baseline, Month 1 through Month 12)
- Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches(Baseline, Month 1 through Month 12)
- Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)(Baseline through Month 12)
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(Month 12)
- Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD)(Baseline, Month 1 through Month 12)
- Overall Mean Patient Global Impression-Improvement (PGI-I) Score(Month 1 through Month 12)
- Overall Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score(Baseline, Month 1 through Month 12)
- Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12(Baseline through Month 12)