A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 89
- 主要终点
- Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug
研究概览
简要总结
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).
Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab
The total duration of the study is planned to be 75 months.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≥15 headache days per month on average during the 3 months prior to screening (visit 1).
- •The participant or parent/caregiver maintain a prospectively collected headache diary
- •NOTE: Additional criteria apply; please contact the investigator for more information.
排除标准
- •The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
- •The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.
- •The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years must be excluded.
- •The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).
- •The participant has a past or current history of cancer.
- •The participant is pregnant or nursing.
- •The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
- •The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.
- •The participant has a current or past medical history of hemiplegic migraine.
- •NOTE: Additional criteria apply; please contact the investigator for more information.
研究组 & 干预措施
Fremanezumab Dose A
Participants weighing < threshold will receive Dose A subcutaneously monthly for 3 months.
干预措施: Fremanezumab (Drug)
Fremanezumab Dose B
Participants weighing ≥ threshold will receive Dose B subcutaneously monthly for 3 months.
干预措施: Fremanezumab (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug
时间窗: Baseline (Day -28 to Day -1), up to Week 12
A migraine day was defined as a day with any of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\], paracetamol etc.), or a headache associated with aura. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in electronic diary (e-diary) for 12-week period) \* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA).
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Baseline up to Month 3)
- Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)(Baseline to last assessment (up to Month 3))
- Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)(Baseline to last assessment (up to Month 3))
- Number of Participants With Any One or More Potentially Clinically Significant Vital Sign Abnormalities(Baseline up to Month 3)
- Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results(Baseline up to Month 3)
- Number of Participants With Abnormal Physical Examination Findings as Identified by the Investigator(Baseline up to Month 3)
- Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline and Month 3)
- Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Period After the First Dose of Study Drug(Baseline (Day -28 to Day -1), up to Week 12)
- Number of Participants Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of Study Drug(Baseline (Day -28 to Day -1) up to Week 12)
- Mean Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During 12-Week Period After the First Dose of Study Drug(Baseline (Day -28 to Day -1), up to Week 12)
- Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire(Baseline, Week 12)
- Mean Change From Baseline in Quality of Life at Week 12, as Measured by Pediatric Quality of Life Inventory (PedsQL) Questionnaire(Baseline, Week 12)
- Number of Participants Developing Anti-drug Antibodies (ADAs) Throughout the Study(Baseline up to Month 3)