A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 (Galcanezumab) in Japanese Patients With Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with 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
- •For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
- •Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (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 50.
排除标准
- •For Chronic Migraine participants:
- •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 other antibodies of calcitonin gene-related peptide (CGRP) or its receptor.
- •Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
- •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.
- •Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).
研究组 & 干预措施
120mg/120mg Galcanezumab - Episodic Migraine (EM)
240 milligram (loading dose) of Galcanezumab at first dosing visit followed by 120 milligram (mg) once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
干预措施: Galcanezumab (Drug)
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
干预措施: Galcanezumab (Drug)
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
干预措施: Galcanezumab (Drug)
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
干预措施: Galcanezumab (Drug)
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
干预措施: Galcanezumab (Drug)
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
干预措施: Galcanezumab (Drug)
结局指标
主要结局
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Up To 16 Months
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
次要结局
- Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score(Baseline, Month 12)
- Pharmacokinetics (PK): Serum Concentration of Galcanezumab(Month 12: Predose)
- Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache(Baseline, Month 12)
- Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache(Baseline, Month 12)
- Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)(Month 12: Predose)
- Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)(Baseline, Month 12)
- Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score(Baseline, Month 12)
- Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1(Baseline, Month 12)
- Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)(Month 12)
- Percentage of Participants Developing Anti-Drug Antibodies (ADA)(Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose)
- Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days(Month 12)
- Mean Change From Baseline in the Number of Headache Days (HDs)(Baseline, Month 12)