A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,130
- 试验地点
- 139
- 主要终点
- Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age
- •Patient signs and dates the informed consent document
- •Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis
- •85% e-diary compliance
- •Total body weight between 99 and 250 lbs, inclusive
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
- •Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
- •History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
- •Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
- •Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma
- •Pregnant or nursing females
- •History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
- •Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer
- •Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Placebo
Matching Placebo
干预措施: Placebo (Drug)
Fremanezumab 675 mg/placebo/placebo
Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
干预措施: Fremanezumab (Drug)
Fremanezumab 675 mg/placebo/placebo
Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
干预措施: Placebo (Drug)
Fremanezumab 675/225/225 mg
Participants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.
干预措施: Fremanezumab (Drug)
结局指标
主要结局
Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Day 1 to Week 12
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug
时间窗: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \* 28. The change is calculated as post-baseline value - baseline value.
次要结局
- Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results(Treatment Days 28, 56 and 84 (or endpoint))
- Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results(Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading reflect the baseline reading performed on Day 0.)
- Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug(Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12))
- Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the 4 Week Period After the First Dose of Study Drug(Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4))
- Prothrombin Time Shifts From Baseline to Endpoint(Baseline (Day 0), Treatment Endpoint (Week 12))
- Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug(Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12))
- Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications(Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12))
- Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity(Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12))
- Electrocardiogram (ECG) Findings Shifts From Baseline to Overall(Baseline (Day 0), Treatment Week 12 (or endpoint))
- Change From Baseline in Migraine-Related Disability Score, As Measured by the 6-Item Headache Impact Test (HIT) At Week 12(Baseline, 12 weeks)
- Participants With Vital Signs Potentially Clinically Significant Abnormal Values(Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading may reflect the baseline reading performed on Day 0.)
- Injection Site Reaction Adverse Events(Day 1 to Week 12)
- Participants With Positive Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) Results After the First Dose of Study Drug(Baseline (Day 0), Treatment Days 28, 56, 84)