Intermediate-size Patient Population Expanded Access Protocol for Tazbentetol in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

Spinogenix27 个研究点分布在 1 个国家开始时间: 2025年7月28日最近更新: 2026年7月17日

试验速览

阶段: 不适用
状态: Available
发起方
试验地点: 27

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this Expanded Access Program is to provide tazbentetol to ALS patients who are not eligible to enroll in an ALS clinical trial. This Expanded Access Program will assess safety and tolerability, and clinical efficacy of tazbentelol.

详细描述

This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to tazbentetol to adult patients with ALS who have progressed following available standard of care.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•ALS diagnosis
•Age 18 -85 years at time of signing informed consent form
•Ineligible for other interventional ALS clinical research participation
•Vital Capacity greater than 35% of predicted capacity for age, height, and sex
•If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking tazbentetol.
•Life expectancy of at least 6 months, according to Investigator's judgement

排除标准

•Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient
•Known ongoing or clinically uncontrolled cardiac disease
•Clinically significant liver disease
•Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement
•Concomitant use of another investigational medical product for treatment of ALS
•Unable to reliably and regularly swallow whole oral medications on a daily basis

研究者

发起方

Spinogenix

申办方类型

Industry

责任方

Sponsor

研究点 (27)

Loading locations...

相似试验

Temporarily Not Available

不适用

INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY

NCT06784297Immunis, Inc.

No Longer Available

不适用

Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)Multiple System Atrophy (MSA)

NCT05086094Biohaven Pharmaceuticals, Inc.

Available

不适用

Intermediate-Size Expanded Access Protocol (EAP) for LP352

NCT06149663Longboard Pharmaceuticals

Available

不适用

Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 MutationAdvanced Non-small Cell Lung CancerCancer

NCT06761976Bayer

Available

不适用

Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple MyelomaMultiple Myeloma

NCT05346835Janssen Scientific Affairs, LLC