EUCTR2008-002062-62-DE进行中（未招募）不适用
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).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). - ALSTAR
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
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
- •ALS-TAL-201:
- •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.
- •ALS-TAL-201-OL:
- •Completed 52 wks treatment in ALS-TAL-201 trial.
- •ALS-TAL-201 and ALS-TAL-201-OL:
- •1) Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
- •2) Willingness and ablility to give written IC prior to performing any open-label extension. 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
- •ALS-TAL-201:
- •1) 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 ECG signs of Brugada syndrome and/ or complete or incomplete RBBB (Right Bundle Branch Block) during screening and/ or baseline visits.
- •6) Patients with clinical signs and symptoms of dementia.
- •7) Known HIV positive.
- •8) History of known sensitivity or intolerability to benzodiazepines.
- •9) Subjects having used within the specified time prior to screening any of the following:
- •- Talampanel (any previous use)
- •- Mecasermin (rhIGF-1) (within 4 weeks prior to screening)
- •- Chronic use of minocycline (14 consecutive days or more within 4 weeks prior to screening)
- •- Chronic use of lithium carbonate use within 4 weeks prior to screening
- •- Use of more than 600mg/day coenzyme Q10 (within 4 weeks prior to screening)
- •- Any marketed drug, (within 12 weeks prior to screening) if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
- •- Subjects participating in any other investigational drug trial and use of any other investigational drug within 12 weeks prior to screening
- •- Taking any drugs which induce or inhibit talampanel metabolism within 2 weeks prior to screening
- •- Taking substrates of CYP2C8 within 2 weeks prior to screening, with the exception of amiodarone and chloroquine that should not be taken within 4 months prior to screening
- •10) Addiction to a drug or substance within the past year prior to screening.
- •11) Subjects unable at time of the screening and baseline visits to comply with the planned schedule of study visits and study procedures
- •ALS-TAL-201-OL:
- •1) Subjects with ECG signs of Brugada syndrome and/ or complete or incomplete RBBB (Right Bundle Branch Block)
- •2) Subjects using any of the following:
- •- Chronic use of lithium carbonate
- •- Mecasermin (rhIGF-1)
- •- Chronic use of minocycline
- •- More than 600mg/day coenzyme Q10
- •- Any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
- •- Participating in any other IMP study and use of any other IMP
- •- Taking any drugs which induce or inhibit talampanel metabolism (Appendix 2)
- •- Taking substrates of CYP2C8 (Appendix 2)
- •ALS-TAL-201 and ALS-TAL-201-OL:
- •1) Females who are pregnant or nursing.
- •2) 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)].
- •3) Any condition which the investigator feels may interfere with participation.
研究者
相似试验
进行中（未招募）
不适用
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).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS).EUCTR2008-002062-62-BETeva Pharmaceutical Industries, Ltd540
已完成
不适用
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery - SAVE-HIP3-I82I82PER-079-08sanofi-aventis Recherche & Development,
进行中（未招募）
不适用
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery - SAVE-HIP2The subjects who will participate to this clinical trial are patients undergoing Hip Fracture Surgery.MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisEUCTR2007-007945-11-PTsanofi-aventis recherche & développement1,000
进行中（未招募）
不适用
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery - SAVE-HIP2The subjects who will participate to this clinical trial are patients undergoing Hip Fracture Surgery.MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisEUCTR2007-007945-11-BGsanofi-aventis recherche & développement1,000
已完成
不适用
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery - SAVE-HIP2PER-080-08sanofi-aventis Recherche & Development,