EUCTR2008-002062-62-ES进行中（未招募）1 期
Estudio multinacional, multicéntrico, randomizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, tolerabilidad y seguridad de Talampanel en pacientes con Esclerosis Lateral Amiotrófica (ELA)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Subjects must meet all the inclusion criteria to be eligible:
- •1) Males and females with definite, probable or probable laboratory-supported ALS according to the World Federation of Neurology revised El Escorial criteria. ALS may be familial or sporadic (Appendix 1).
- •2) Subjects must be between 18 and 80 years of age (inclusive).
- •3) Subjects must have experienced their first ALS symptoms within 3 years inclusive prior to the screening visit.
- •4) Subjects must have a Slow VC score equal to or greater than 70% of the predicted value for gender, height and age at the screening and baseline visits.
- •5) The sum of the 3 respiratory items from the ALSFRS-R must total at least 10 points at the screening and baseline visits.
- •6) Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to the screening visit.
- •7) Participants must be able to take oral medication at time of screening and baseline visits.
- •8) Subjects must be willing and able to give written informed consent prior to performing any study procedures. If the subject is unable to write, he/she may give oral consent or if not possible visual consent (such as head nodding) in the presence of at least one witness as provided in local country legislation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •Any of the following will exclude the subject from entering the study:
- •1) The use of mechanical ventilation (invasive or non-invasive, including Continuous Positive Airway Pressure (CPAP) for any part of the day or night or Bilevel Positive Airway Pressure (BiPap) for any part of the day prior to the screening visit or baseline.
- •2) Feeding tube present at time of screening or baseline.
- •3) Any clinically significant or unstable medical or surgical condition including cardiovascular, hepatic, pulmonary, renal, autoimmune, endocrine, metabolic, malignancy or psychiatric or any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study.
- •4) Patients whose mean QTc value calculated from 3 baseline measurements is above 450msec
- •5) Patients with clinical signs and symptoms of dementia
- •6) Known HIV positive.
- •7) History of known sensitivity or intolerability to benzodiazepines.
- •8) Subjects having used within the specified time prior to screening any of the following medicinal products (as specified in the protocol).
- •9) Females who are pregnant or nursing.
- •10) Females of child-bearing potential who do not practice medically acceptable methods of contraception [surgical sterilization, intrauterine device (IUD), hormonal preparations, or double barrier method (e.g. condom or diaphragm, and spermicide)].
- •11) Addiction to a drug or substance within the past year prior to screening.
- •12) Any condition which the investigator feels may interfere with participation in the study.
- •13) Subjects unable at time of the screening and baseline visits to comply with the planned schedule of study visits and study procedures.
研究者
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