EUCTR2010-022818-19-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 915
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
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •2. Subject is between 18 and 80 years of age (inclusive) on Day 1.
- •3. Subject is diagnosed with sporadic or familial ALS.
- •4. Subject had onset of first ALS symptoms =24 months prior to Day 1.
- •5. Subject meets the possible, laboratory-supported probable, probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology El Escorial criteria (revised according to the Airlie House Conference 1998). Subjects meeting the definition of possible ALS” must have upper motor neuron (UMN) and lower motor neuron (LMN) signs/symptoms in at least 1 region).
- •6. Subject has an upright SVC =65% of predicted value for age, height, and gender at screening.
- •7. Subject has not taken riluzole for at least 30 days prior to Day 1, or has been on a stable dose of riluzole for at least 60 days prior to Day 1. (Riluzole-naïve subjects are permitted in the study.)
- •8. Subject is medically able to undergo the study procedures and to adhere to the visit schedule at the time of study entry.
- •9. Subject is able to take oral treatment without crushing or breaking the tablets at the time of study entry as assessed by the site Investigator.
- •10. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment.
- •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 915
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject in whom causes of neuromuscular weakness other than ALS have not been excluded.
- •2. Subject with significant cognitive impairment, clinical dementia, or psychiatric illness
- •3. Subject with a diagnosis of other neurodegenerative diseases (e.g., Parkinson’s disease, Alzheimer’s disease, etc.)
- •4. Subject with a clinically significant history of unstable or severe cardiac, oncologic, hepatic, or renal disease, or other medically significant illness
- •5. Subject with a clinically significant pre-existing pulmonary disorder not attributed to ALS
- •6. Subject with a history of severe drug allergy or severe allergic disease (anaphylactic shock)
- •7. Subject with clinically significant ECG abnormalities at the Screening visit (e.g. QTc >500 msec (where QTc is the interval between the start of the QRS complex and the end of the T wave corrected for heart rate), or acute ST segment elevations)
- •8. Subject with clinically significant abnormal clinical laboratory values, as determined by the Investigator at the Screening visit
- •9. Subject with absolute neutrophil count (ANC) <1.96 x 1000/µL at the Screening visit or any documented history of neutropenia
- •10. Subject with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper limit of normal at the Screening visit
- •11. Subject with creatinine clearance (CrCl, calculated according to the Modification of Diet in Renal Disease equation) =50 mL/minute at the Screening visit
- •12. Pregnant women or women breastfeeding
- •13. Subject with a history of alcohol or drug abuse within 1 year of Day 1, as determined by Investigator
- •14. Subject unlikely to comply with study requirements
- •15. Subject who has been exposed to any other experimental agent (off-label use or investigational) within 30 days of Day 1.
- •16. Subject with prior exposure to dexpramipexole
- •17. Subject taking pramipexole or other dopamine agonists
研究者
相似试验
已完成
2 期
A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19NL-OMON51156Molecular Partners AG200
招募中
4 期
Treatment of Verruca Plana by external application of tubeimoside injection: a randomized, double-blind, placebo-controlled, multicenter clinical trial.Flat WartITMCTR2000003368Shaanxi Provincial Hospital of Traditional Chinese Medicine
已完成
2 期
A randomized, double-blind, placebo-controlled, multicenter Phase II study to determine efficacy and safety of IFX-1 in subjects with moderate to severe hidradenitis suppurativaNL-OMON46646InflaRx GmbH4
尚未招募
1 期
Clinical evaluation for traditional Chinese medicine combined with antibiotics in the treatment of bacterial pneumonia in childreBacterial pneumonia in childrenITMCTR1900002538Affiliated Hospital of Changchun University of Traditional Chinese Medicine
招募中
1 期
A randomized, double-blind, placebo-controlled, multicenter clinical study on the efficacy and safety of hongjing-1 in the treatment of impotenceErectile DysfunctionITMCTR2100004505The Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine