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Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor

2026年6月23日 更新者：AbbVie

A Phase 2b Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Treatment of Upper Limb Essential Tremor in Adults

Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating. This study will assess if AGN-151607-DP is safe and effective by assessing adverse events and change in disease activity in adult participants with UL ET.

AGN-151607-DP is an investigational drug being developed to treat UL ET. Participants will be randomly placed in treatment groups to receive either AGN151607-DP or matching placebo. Approximately 94 adult participants with upper limb essential tremor will be enrolled in approximately 40 sites in the United States/Canada.

Participants will receive intramuscular injections of AGN-151607-DP or matching placebo. Duration of the study is approximately 72 weeks.

The effect of the treatment will be checked by completion of questionnaires and side effects will be monitored by medical assessments.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

94

阶段

  • 阶段2

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。

学习联系方式

学习地点

  • 美国
    • California
      • Fresno、California、美国、93710
        • 招聘中
        • Neuro Pain Research Center /ID# 277899
    • Florida
      • Boca Raton、Florida、美国、33486
        • 招聘中
        • Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079
      • Orlando、Florida、美国、32803-1839
        • 招聘中
        • Charter Research - Winter Park /ID# 277875

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Minimum body weight of 50 kg (110 pounds) at Screening.

  • Diagnosis of essential tremor (ET) in accordance with the modified Tremor Research Investigation Group (TRIG) criteria, as follows:

    • Bilateral postural tremor with or without kinetic tremor, involving hands and forearms
    • Tremor of other body parts may or may not be present in addition to upper limb (UL) tremor
    • Bilateral tremor may or may not be asymmetric
    • Tremor that is reported by the participant to be persistent, although the amplitude may fluctuate.

Exclusion Criteria:

  • History of any medical condition that may put the participant at increased risk with exposure to purified botulinum toxin type A complex, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease that might interfere with neuromuscular junctional disorders.
  • History of an allergic reaction to or significant sensitivity to AGN-151607-DP or its excipients and/or other botulinum toxins.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：AGN-151607-DP
Participants will receive AGN-151607-DP.
药品：AGN-151607-DP
肌肉注射
安慰剂比较：Placebo for AGN-151607-DP
Participants will receive Placebo for AGN-151607-DP.
药品：AGN-151607-DP 安慰剂
肌肉注射

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
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS)
大体时间：72 weeks
TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor).
72 weeks
Number of Participants with Adverse Events (AEs)
大体时间：72 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
72 weeks

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL)
大体时间：72 weeks
TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor. Items are scored from 0 to 4, with 0 indicating no tremor and 4 indicating a severe tremor.
72 weeks
Change From Baseline in Clinical Global Impression of Severity (CGIS)
大体时间：72 weeks
CGI-S is a single item used to measure the clinician's impression of the current severity of the patient's essential tremor. The measure uses a 5-point rating scale with scores ranging none to very severe.
72 weeks

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

AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

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)

2026年6月18日

初级完成 (估计的)

2028年11月1日

研究完成 (估计的)

2028年11月1日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年6月23日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年6月29日

上次提交的符合 QC 标准的更新

2026年6月23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

其他研究编号

  • M25-850

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

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD 共享时间框架

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD 共享访问标准

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 共享支持信息类型

  • 研究方案
  • 树液

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.

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