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临床试验/NCT05158166
NCT05158166已完成1 期

DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年10月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
22
试验地点
2
主要终点
Our primary outcome is the difference in VHI-10 score at 6 weeks after injection with DAXI.

研究概览

简要总结

Spasmodic Dysphonia (SD) is a neurologic condition causing inappropriate contraction of the laryngeal musculature, leading to abnormal voicing. The three types (adductor, abductor, and mixed) affect varying muscle groups which produce characteristic voice patterns. The vast majority of patients with SD have adductor type, which impacts the lateral cricoarytenoid and thyroarytenoid muscle complex. While many treatment modalities have been investigated, the most effective treatment is botulinum toxin injection to these muscle groups, performed transcervically with or without electromyography (EMG) guidance. Patients undergoing this treatment typically require re-injection every 3 months. Due to its specialized nature, the laryngeal injections are not performed routinely outside of academic medical centers; thus, patients may come from a distance to receive this treatment. Both due to the significant impact on voice quality when the injections wear off and the sometimes challenging access to treatment, a longer-acting agent is desired.

Injectible daxibotuliumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer a longer-lasting result when compared with onabotulinumtoxinA.

Thus, a study examining the effect of DAXI for patients with adductor spasmodic dysphonia is proposed. This study aims to assess the efficacy of DAXI for transcervical laryngeal injection in patients with adductor spasmodic dysphonia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • greater than 18
  • diagnosis of adductor spasmodic dysphonia
  • previous successful treatment with BotoxA
  • stabilized dose for last 3 treatments

排除标准

  • age less than 18
  • exclusively having other neurologic conditions such as:
  • abductor spasmodic dysphonia
  • Multiple sclerosis
  • Parkinson's disease
  • Essential tremor

研究组 & 干预措施

Administration of Daxi

Experimental

Injectible daxibotulinumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) is an investigational botulinum toxin type A which has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer longer-lasting results when compared with onabotulinumtoxinA. Dosage will be same number of units as prior Botox A dose.

干预措施: DaxibotulinumtoxinA (Drug)

结局指标

主要结局

Our primary outcome is the difference in VHI-10 score at 6 weeks after injection with DAXI.

时间窗: 6 weeks

This will be determined using a paired t-test with subjects pre-treatment VHI-10 scores as a control.

次要结局

  • A secondary outcome will be comparing the duration of effect of DAXI with patients' prior Botox treatment.(Up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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