EUCTR2015-000460-34-AT进行中（未招募）1 期
Effects of Acetyl-DL-Leucine on cerebellar ataxia - a multinational, multicenter, randomized, double-blind, placebo-controlled, 2-way crossover phase III trial (ALCAT) - ALCAT
Hospital of the University of Munich0 个研究点目标入组 108 人开始时间: 2015年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
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
- •Subjects will only be included in the study if they meet all of the following criteria:
- •1) Clinically confirmed cerebellar ataxia (CA) with a total SARA-Score = 3 (range 0-40) of hereditary or non-hereditary degenerative type
- •2) Patient did not receive any of the following prohibited medication within 4 weeks prior to randomization: aminopyridines, Acetyl-DL-Leucine, Riluzole, Gabapentin, Varenicline, Chlorzoxazone
- •3) The ability to follow study instructions and likely to attend and complete all required visits
- •4) Written informed consent of the subject prior to any study specific intervention
- •5) Age = 18 years
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Subjects will not be included in the study if any of the following criteria applies:
- •1) Subject is not able to give consent
- •2) Onset of ataxia in association with stroke, encephalitis, sepsis, hyperthermia or heat stroke
- •3) Toxic causes for ataxia of cerebellar type
- •4) Rapid progression of ataxia (development of severe ataxia in less than 12 weeks)
- •5) Subject suffers from any of the following:
- •ochronic diarrhea
- •ounexplained visual loss
- •omalignancies
- •oinsulin-dependent diabetes mellitus
- •6) Ataxia due to multiple sclerosis, ischemia, hemorrhage or tumor of the posterior fossa as confirmed by imaging
- •7) Ataxia due to clinical likely multisystem atrophy type C (MSA-C)
- •8) Diagnosis of clinical likely Friedreich ataxia
- •9) Known history of hypersensitivity to the investigational drug or derivates
- •10) Liver failure defined as AST/ALT > 300 U/l
- •11) Simultaneous participation in another clinical trial or participation in any clinical trial involving administration of an investigational medical product within 30 days prior to the beginning of the clinical trial
- •12) Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
- •13) Known or persistent abuse of medication, drugs or alcohol
- •14) Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration as listed in the patient informed consent form
- •15) Current or planned pregnancy or nursing women
- •16) Patient has received any of the following prohibited medication within 4 weeks prior to randomization
- •oAminopyridines (including substained-release form)
- •oAcetyl-DL-Leucine
- •oGabapentin
- •oVarenicline
- •oChlorzoxazone
研究者
相似试验
已完成
3 期
Effects of Acetyl-DL-Leucine on cerebellar ataxia - a multinational, multicenter, randomized, double-blind, placebo-controlled, 2-way crossover phase III trialG11.0G11.1G11.2G11.8G11.9Congenital nonprogressive ataxiaEarly-onset cerebellar ataxiaLate-onset cerebellar ataxiaOther hereditary ataxiasHereditary ataxia, unspecifiedDRKS00009733Klinikum der Universität München, Campus Großhadern108
进行中（未招募）
1 期
Effects of Acetyl-DL-Leucine on cerebellar ataxiaEUCTR2015-000460-34-DEHospital of the University of Munich108
招募中
2 期
Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A multinational, multi-center, open-label, rater-blinded Phase II studyATAXIA TELANGIECTASIAG11.3Cerebellar ataxia with defective DNA repairDRKS00020511IntraBio Ltd30
进行中（未招募）
1 期
A safety and efficacy study of N-Acetyl-L-Leucine on Ataxia-TelangiectasiaTo demonstrate that N-Acetyl-L-Leucine is effective in improving symptoms, functioning, and quality of life in patients with Ataxia-Telangiectasia (A-T)EUCTR2018-004407-39-GBIntraBio Ltd.39
进行中（未招募）
1 期
A safety and efficacy study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia.Ataxia-Telangiectasia (A-T)MedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-004407-39-DEIntraBio Ltd39