此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一项测试 Fremanezumab 是否能有效预防儿童和青少年偏头痛的研究

2026年6月26日 更新者：Teva Branded Pharmaceutical Products R&D LLC

一项评估每月皮下注射 Fremanezumab 预防性治疗 6 至 17 岁儿童发作性和慢性偏头痛的长期安全性、耐受性和有效性的多中心、开放标签研究

该研究的主要目的是评估皮下注射 fremanezumab 预防性治疗 6 至 17 岁儿科参与者（纳入关键研究时）的偏头痛的长期安全性和耐受性。

次要目标是评估皮下注射 fremanezumab 在患有偏头痛的儿科参与者中的疗效，并评估 fremanezumab 的免疫原性以及 ADAs 对暴露于 fremanezumab 的儿科参与者临床结果的影响。

研究的总持续时间计划长达 60 个月。

研究概览

地位

完全的

条件

干预/治疗

详细说明

研究人群将由 3 个参与者亚组组成，如下所示：

  • 从关键的 3 期儿科疗效研究（研究 TV48125-CNS-30082 和 TV48125-CNS-30083）中转出的参与者
  • 从 1 期儿科药代动力学研究（研究 TV48125-CNS-10141）中转出的参与者
  • 从关键的 3 期儿科疗效研究（研究 TV48125-CNS-30082 和 TV48125-CNS-30083）转入的参与者仅用于安全随访和抗药物抗体 (ADA) 评估

研究类型

介入性

注册 (实际的)

499

阶段

  • 第三阶段

扩展访问

可用的 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Be’er Ya‘aqov、以色列、7033001
        • Teva Investigational Site 80170
      • Haifa、以色列、3104802
        • Teva Investigational Site 80166
      • Holon、以色列、58100
        • Teva Investigational Site 80168
      • Jerusalem、以色列、9124001
        • Teva Investigational Site 80169
      • Ramat Gan、以色列、5265601
        • Teva Investigational Site 80167
      • Safed、以色列、1311001
        • Teva Investigational Site 80164
      • Tel Aviv、以色列、6423906
        • Teva Investigational Site 80165
  • 加拿大
    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L1
        • Teva Investigational Site 11182
      • Ottawa、Ontario、加拿大、K2G 1W2
        • Teva Investigational Site 11179
    • Quebec
      • Montreal、Quebec、加拿大、H3H 2R9
        • Teva Investigational Site 11181
  • 德国
      • Bad Homburg、德国、61350
        • Teva Investigational Site 32728
      • Berlin、德国、13353
        • Teva Investigational Site 32729
      • Leipzig、德国、04177
        • Teva Investigational Site 32726
  • 意大利
      • Florence、意大利、50139
        • Teva Investigational Site 30230
      • Milan、意大利、20132
        • Teva Investigational Site 30239
      • Milan、意大利、20133
        • Teva Investigational Site 30228
      • Milan、意大利、20148
        • Teva Investigational Site 30226
      • Padua、意大利、35128
        • Teva Investigational Site 30238
      • Pavia、意大利、27100
        • Teva Investigational Site 30227
      • Rome、意大利、00163
        • Teva Investigational Site 30225
  • 波兰
      • Gdansk、波兰、80-389
        • Teva Investigational Site 53441
      • Kielce、波兰、25-316
        • Teva Investigational Site 53437
      • Krakow、波兰、30-363
        • Teva Investigational Site 53443
      • Krakow、波兰、30-539
        • Teva Investigational Site 53452
      • Lublin、波兰、20-582
        • Teva Investigational Site 53440
      • Poznan、波兰、60-355
        • Teva Investigational Site 53439
      • Poznan、波兰、61-731
        • Teva Investigational Site 53451
      • Szczecin、波兰、70-111
        • Teva Investigational Site 53442
  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • Teva Investigational Site 14319
      • Colorado Springs、Colorado、美国、80907
        • Teva Investigational Site 14368
    • Florida
      • Jacksonville、Florida、美国、32256
        • Teva Investigational Site 14244
      • Miami、Florida、美国、33155
        • Teva Investigational Site 14325
      • West Palm Beach、Florida、美国、33407
        • Teva Investigational Site 14250
      • West Palm Beach、Florida、美国、33409
        • Teva Investigational Site 14255
    • Georgia
      • Atlanta、Georgia、美国、30328
        • Teva Investigational Site 14243
      • Savannah、Georgia、美国、31406
        • Teva Investigational Site 14258
    • Illinois
      • Hoffman Estates、Illinois、美国、60169
        • Teva Investigational Site 14263
    • Kansas
      • Wichita、Kansas、美国、67206
        • Teva Investigational Site 14245
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • Teva Investigational Site 14327
    • Louisiana
      • Covington、Louisiana、美国、70433
        • Teva Investigational Site 14360
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Teva Investigational Site 14365
    • Massachusetts
      • Waltham、Massachusetts、美国、02451
        • Teva Investigational Site 14246
    • Michigan
      • Ann Arbor、Michigan、美国、48104
        • Teva Investigational Site 14251
    • Minnesota
      • Minneapolis、Minnesota、美国、55402
        • Teva Investigational Site 14270
    • Mississippi
      • Ridgeland、Mississippi、美国、39157
        • Teva Investigational Site 14376
    • Missouri
      • Bridgeton、Missouri、美国、63044-2513
        • Teva Investigational Site 14256
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • Teva Investigational Site 14371
    • New York
      • Amherst、New York、美国、14226
        • Teva Investigational Site 14276
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Teva Investigational Site 14377
      • Raleigh、North Carolina、美国、27607
        • Teva Investigational Site 14248
    • Ohio
      • Cincinnati、Ohio、美国、45229-3039
        • Teva Investigational Site 14264
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • Teva Investigational Site 14257
      • Tulsa、Oklahoma、美国、74136
        • Teva Investigational Site 14363
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104-4318
        • Teva Investigational Site 14364
    • Tennessee
      • Bristol、Tennessee、美国、37620
        • Teva Investigational Site 14374
    • Texas
      • Austin、Texas、美国、78731
        • Teva Investigational Site 14252
      • Austin、Texas、美国、78759
        • Teva Investigational Site 14273
      • Dallas、Texas、美国、75235-7701
        • Teva Investigational Site 14367
    • Utah
      • Salt Lake City、Utah、美国、84109
        • Teva Investigational Site 14375
    • Virginia
      • Norfolk、Virginia、美国、23510
        • Teva Investigational Site 14323
  • 芬兰
      • Helsinki、芬兰、00380
        • Teva Investigational Site 40053
      • Kuopio、芬兰、70210
        • Teva Investigational Site 40049
      • Oulu、芬兰、90100
        • Teva Investigational Site 40054
      • Tampere、芬兰、33521
        • Teva Investigational Site 40052
  • 荷兰
      • Doetinchem、荷兰、7009 BL
        • Teva Investigational Site 38138
      • Nijmegen、荷兰、6532 SZ
        • Teva Investigational Site 38135
      • Rotterdam、荷兰、3015 GD
        • Teva Investigational Site 38136
  • 西班牙
      • Barcelona、西班牙、08035
        • Teva Investigational Site 31271
      • Valencia、西班牙、46026
        • Teva Investigational Site 31270
      • Valladolid、西班牙、47010
        • Teva Investigational Site 31265

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 17年 (孩子)

接受健康志愿者

不

描述

纳入标准：

从关键功效研究（TV48125-CNS-30082 或 TV48125-CNS-30083）滚动过来的参与者的纳入标准：

  • 参与者已完成关键功效研究，并且研究者或申办者认为能够以安全且合规的方式完成研究。
  • 参与者可以继续使用他们在关键疗效研究期间服用的预防性药物的稳定剂量/方案。
  • 参与者继续满足从关键疗效研究/
  • 参与者已根据当地护理标准和时间表接受了所有推荐的适合年龄的疫苗。
  • 参与者在研究登记当天的体重至少为 17.0 公斤。

注意：附加标准适用；请联系调查员以获取更多信息。

从第 1 阶段儿科药代动力学研究（研究 TV48125-CNS-10141）转过来的参与者的纳入标准：

  • 通过输入 28 天中至少 21 天的头痛数据（约 75% 的日记合规性），参与者/护理人员已证明在 28 天基线期间遵守电子头痛日记。
  • 参与者已根据当地护理标准和时间表接受了所有推荐的适合年龄的疫苗。
  • 参与者在研究登记当天的体重至少为 17.0 公斤。
  • 在研究登记当天，参与者的体重指数范围为第 95 个百分位数的第 5% 到 120%（含）。
  • 不使用预防性药物或使用不超过 2 种预防性药物治疗偏头痛或其他疾病，只要剂量和方案在筛选前至少 2 个月保持稳定（访视 1）。

注意：附加标准适用；请联系调查员以获取更多信息。

仅针对安全性和抗药物抗体 (ADA) 评估的关键功效研究（TV48125-CNS-30082 和 TV48125-CNS-30083）的参与者纳入标准：

• 如果参与者在知情同意书上签名并注明日期，或者在父母或监护人的同意下（如果参与者小于同意年龄）并征得参与者的同意，则可以将参与者包括在本研究中。

排除标准：

从关键功效研究（TV48125-CNS-30082 或 TV48125-CNS-30083）滚动过来的参与者的排除标准：

  • 根据研究者的判断，参与者在进入研究时有临床意义的异常发现，包括血液学、血液化学、凝血试验或尿液分析值/发现（异常测试可重复确认）。
  • 根据研究者的判断，参与者在过去 2 年内有临床上显着的精神疾病史、任何自杀未遂史或有特定计划的自杀意念史。
  • 参与者有持续感染或已知的人类免疫缺陷病毒感染史、结核病、莱姆病或慢性乙型或丙型肝炎，或已知的 2019 冠状病毒病 (COVID-19) 活动性感染。
  • 参与者有对注射蛋白质（包括单克隆抗体）的超敏反应史，或史蒂文斯-约翰逊综合征或中毒性表皮坏死松解综合征史，或参与者同时使用拉莫三嗪。
  • 参与者在筛选前的 12 周内接种了减毒活疫苗（例如，鼻内流感疫苗，以及麻疹、腮腺炎和风疹疫苗）。 注意：如果在研究期间出现医疗需要，参与者可能会接种减毒活疫苗。
  • 参与者怀孕或哺乳。
  • 根据研究者的判断，参与者在基线 12 导联 ECG 上有被认为具有临床意义的异常发现。
  • 患者目前或既往有偏瘫性偏头痛病史。

注意：附加标准适用；请联系调查员以获取更多信息。

从 1 期药代动力学研究 (TV48125-CNS-10141) 滚动过来的参与者的排除标准：

  • 参与者有任何具有临床意义的心血管疾病（包括先天性心脏异常或血栓栓塞事件）、内分泌、胃肠道、泌尿生殖系统、血液学、肝脏、免疫学、神经学、眼科、肺部、肾脏疾病或感染并发症，由研究者自行决定.
  • 根据研究者的判断，参与者在过去 2 年内有临床上显着的精神疾病史、任何自杀未遂史或有特定计划的自杀意念史。
  • 参与者有持续感染或已知的人类免疫缺陷病毒感染史、结核病、莱姆病或慢性乙型或丙型肝炎，或已知的 2019 冠状病毒病 (COVID-19) 活动性感染。
  • 参与者有对注射蛋白质（包括单克隆抗体）的超敏反应史，或史蒂文斯-约翰逊综合征或中毒性表皮坏死松解综合征史，或参与者同时使用拉莫三嗪。
  • 参与者在筛选前的 12 周内接种了减毒活疫苗（例如，鼻内流感疫苗，以及麻疹、腮腺炎和风疹疫苗）。 注意：如果在研究期间出现医疗需要，参与者可能会接种减毒活疫苗。
  • 参与者怀孕或哺乳。
  • 根据研究者的判断，参与者在基线 12 导联 ECG 上有被认为具有临床意义的异常发现。
  • 患者目前或既往有偏瘫性偏头痛病史。

注意：附加标准适用；请联系调查员以获取更多信息。

从安全性和抗药物抗体 (ADA) 评估的关键功效研究（TV48125-CNS-30082 和 TV48125-CNS-30083）中滚动过来的参与者的排除标准：仅适用：不适用

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：弗雷曼珠单抗
每 3 个月将根据参与者的体重确定或适当调整 Fremanezumab 的给药剂量。
药品：弗雷曼珠单抗

体重≥阈值的参与者将每月皮下注射剂量 A。

体重 < 阈值的参与者将每月皮下注射剂量 B。

每月一次皮下注射，每 3 个月根据参与者的体重酌情确认或调整一次。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Adverse Events (AEs)
大体时间：Day 1 up to Day 393
An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Day 1 up to Day 393
Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results
大体时间：Day 1 up to Day 253
Serum chemistry tests with clinically significant abnormal findings included: alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase ≥2*upper limit of normal (ULN); gamma glutamyl transferase ≥3* ULN; bilirubin ≥34.2 micromole/liter (umol/L); and urea nitrogen ≥9 umol/L. Hematology tests with clinically significant abnormal findings included: hemoglobin ≤100 grams (g)/L (female) or ≤100 g/L (male), hematocrit <0.32 L/L (male), leukocytes ≤3*10^9 cells/L or ≥20*10^9 cells/L, neutrophils ≤1*10^9 cells/L, eosinophils/leukocytes ≥10%, and platelets ≤75x10^9/L. Coagulation parameter test with clinically significant abnormal findings included: prothrombin international normalized ratio (INR) >1.5. Urinalysis laboratory tests with clinically significant abnormal findings included: urine protein and urine glucose ≥2 units (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Day 1 up to Day 253
Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)
大体时间：Baseline to last assessment (up to Day 253)
The number of participants with a shift from Baseline (Normal, Abnormal CS [Clinically Significant], or Abnormal NCS [Not Clinically Significant]) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF). Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline to last assessment (up to Day 253)
Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)
大体时间：Baseline to last assessment (up to Day 253)
The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QTcB, and QTcF. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline to last assessment (up to Day 253)
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
大体时间：Day 1 up to Day 253
Potentially clinically significant abnormal vital signs findings included any one of the following: Pulse rate ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm, or ≤50 bpm and decrease from baseline of ≥15 bpm, or ≤60 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure ≤80 millimeters of mercury (mmHg) and decrease of ≥20 mmHg, or ≤85 mmHg and decrease of ≥20 mmHg, or ≥150 mmHg and increase of ≥20 mmHg; diastolic blood pressure ≤37 mmHg and decrease of ≥15 mmHg, or ≤44 mmHg and decrease of ≥15 mmHg, or ≥100 mmHg and increase of ≥15 mmHg, or ≥93 mmHg and increase of ≥15 mmHg; respiratory rate <15 or <10 breaths/minute; and body temperature ≥38.3 degrees Celsius and change ≥1.1 degrees Celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Day 1 up to Day 253
Number of Participants With Shift From Baseline to Last Assessment in Physical Examination Findings
大体时间：Baseline to last assessment (up to Day 393)
The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following organ systems examination is reported by treatment group: general appearance; head, eyes, ears, nose, and throat (HEENT); chest and lungs; cardiovascular; abdomen; musculoskeletal; skin; lymph nodes; neurological, and extremities/back. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline to last assessment (up to Day 393)
Number of Participants With Suicidal Ideation or Behavior, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
大体时间：Day 1 up to Day 393
C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.
Day 1 up to Day 393

次要结果测量

结果测量
措施说明
大体时间
Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity
大体时间：Baseline, Months 1, 5, and 9
A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A day with headache pain that lasted ≥2 hours with a peak severity of at least moderate severity or a day where the participant used acute headache medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in in electronic diary [e-diary] for 4-week period) * 28.
Baseline, Months 1, 5, and 9
Mean Change From Baseline in the Monthly Average Number of Migraine Days
大体时间：Baseline, Months 1, 5, and 9
A migraine day was defined as a day with at least one of the following: A calendar day (0:00 to 23:59) demonstrating ≥2 consecutive hours of a headache meeting criteria for migraine with or without aura, or a calendar day (0:00 to 23:59) demonstrating ≥2 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing, or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in e-diary for 4-week period) * 28.
Baseline, Months 1, 5, and 9
Percentage of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Migraine Days
大体时间：Months 1, 5, and 9
A migraine day was defined as a day with at least one of the following: A calendar day (0:00 to 23:59) demonstrating ≥2 consecutive hours of a headache meeting criteria for migraine with or without aura, or a calendar day (0:00 to 23:59) demonstrating ≥2 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing, or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in e-diary for 4-week period) * 28.
Months 1, 5, and 9
Percentage of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity
大体时间：Months 1, 5, and 9
A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A day with headache pain that lasted ≥2 hours with a peak severity of at least moderate severity or a day where the participant used acute headache medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in in electronic diary [e-diary] for 4-week period) * 28.
Months 1, 5, and 9
Mean Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medications
大体时间：Baseline, Months 1, 5, and 9
Participants recorded any headache medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken each day in their electronic headache diary device. Acute headache medication included triptans and ergot compounds. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in e-diary for 4-week period) * 28.
Baseline, Months 1, 5, and 9
Mean Change From Baseline in Migraine-related Disability Score, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire
大体时间：Baseline, Months 3, 6, 9, and 14
The PedMIDAS is a scale developed to assess headache-related disability which can be self-administered by the participant or administered by a caregiver. It has been validated in participants aged 4 to 18 years and includes 3 subscales: the impact of headache on school performance (range of scores 0-92), disability at home (range of scores 0-92), social/sport functioning (range of scores 0-92). The subscales are added to get the total score with a range 0 to 276. The total score was used for grading of disability, with 4 score categories of 0 to 10, 11 to 30, 31 to 50, and 51-276 interpreted as disability grades 1 (little or no disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. Higher total scores indicated severe disability. The change from baseline score is reported with a range of -276 to 276 with higher scores indicating more severe disability.
Baseline, Months 3, 6, 9, and 14
Number of Participants Developing Antidrug Antibodies (ADAs) Throughout the Study
大体时间：Day 1 up to Day 393
Number of participants who developed ADAs were reported.
Day 1 up to Day 393

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Teva Branded Pharmaceutical Products R&D LLC

调查人员

  • 研究主任：Teva Medical Expert, MD、Teva Branded Pharmaceutical Products R&D LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月16日

初级完成 (实际的)

2025年8月15日

研究完成 (实际的)

2025年12月22日

研究注册日期

首次提交

2020年8月24日

首先提交符合 QC 标准的

2020年8月27日

首次发布 (实际的)

2020年8月28日

研究记录更新

最后更新发布 (实际的)

2026年7月24日

上次提交的符合 QC 标准的更新

2026年6月26日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TV48125-CNS-30084
  • 2019-002056-16 (EudraCT编号)
  • 2024-512837-34-00 (克蒂斯)
  • EMEA-001877-PIP01-15 (其他标识符：EMA paediatric Investigation plan number (PIP))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可能会要求访问患者水平的数据和相关研究文件，包括研究方案和统计分析计划。 申请将根据科学价值、产品批准状态和利益冲突进行审查。 患者层面的数据将被去识别化，研究文件将被编辑，以保护试验参与者的隐私和商业机密信息。 请发送电子邮件至 USMedInfo@tevapharm.com 提出您的请求

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅