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临床试验/NL-OMON52262
NL-OMON52262已完成3 期

A PHASE 3, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RELDESEMTIV IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) - COURAGE-ALS

Cytokinetics Inc0 个研究点目标入组 10 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
10
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64（—）

入选标准

  • •Males or Females between the ages of 18 and 80 years of age, inclusive
  • •Diagnosis of familial or sporadic ALS (defined as meeting the
  • •laboratory-supported probable, probable, or definite criteria for ALS according
  • •to the World Federation of Neurology El Escorial criteria published in 2000
  • •[Brooks 2000]). Patients who meet the possible criteria are eligible if they
  • •have lower motor neuron findings; those who have purely upper motor neuron
  • •findings are ineligible.
  • •First symptom of ALS <= 24 months prior to screening. The qualifying first
  • •symptoms of ALS are limited to manifestations of weakness in extremity, bulbar,
  • •or respiratory muscles. Cramps, fasciculations, or fatigue should not be taken
  • •in isolation as a first symptom of ALS.
  • •ALSFRS-R total score <= 44 at screening. Patients with a total score of 45 or
  • •higher may be rescreened 60±7 days following the original screening date and be
  • •deemed eligible if their ALSFRS-R total score is <= 44 or if their score is 2 or
  • •more points less than at initial screening.
  • •Such patients must continue to meet all other inclusion/exclusion criteria at
  • •the time of rescreening.
  • •Upright FVC >= 65.0% of predicted for age, height, sex and ethnicity at
  • •screening according to
  • •Global Lung Initiative equation
  • •Able to perform reproducible pulmonary function tests defined as being able
  • •to perform FVC at screening with variability of the 2 highest raw values of
  • •less than 10% with a maximum of 5 trials permitted. Screening FVC results must
  • •be reviewed and approved by the central review process prior to randomization.
  • •Must be either on riluzole for >= 30 days prior to screening or have not taken
  • •it for at least 30 days
  • •prior to screening
  • •Must have completed at least 2 cycles of edaravone at the time of screening
  • •or have not received it for at least 30 days prior to screening
  • •Able to swallow whole tablets at the time of screening
  • •. Clinical laboratory findings within the normal range, or if outside the
  • •normal range, not deemed clinically significant by the Investigator, except as
  • •specifically indicated as laboratory exclusion

排除标准

  • •eGFRCr and eGFRCysC < 45.0 mL/min/1.73 m2 at screening
  • •Urine protein/creatinine ratio > 1 mg/mg (113 mg/mmol) at screening
  • •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3-times
  • •the upper limit of normal (ULN)
  • •Total bilirubin (TBL), direct or indirect bilirubin above the ULN.
  • •Cognitive impairment, related to ALS or otherwise that impairs the patient*s
  • •ability to understand and/or comply with study procedures and provide informed
  • •Other medically significant neurological conditions that could interfere with
  • •the assessment of ALS
  • •symptoms, signs or progression.
  • •Presence at screening of any medically significant cardiac, pulmonary,
  • •gastrointestinal, musculoskeletal, or psychiatric illness that might interfere
  • •with the patient*s ability to comply with study procedures or that might
  • •confound the interpretation of clinical safety or efficacy data
  • •Has a tracheostomy

研究者

发起方
Cytokinetics Inc

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