NCT01306929已完成2 期
A Multi-Center, North American, Open-Label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington's Disease (Open-HART).
Prilenia0 个研究点目标入组 134 人开始时间: 2011年3月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 主要终点
- Number of Patients With at Least One Adverse Event
研究概览
简要总结
Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to, and has provided written Informed Consent prior to any study related procedure.
- •Patient has completed the HART (ACR16C009) or the PRIDE-HD (TV7820- CNS-20002) studies and had remained on IMP during the full on-treatment part of the study (including de-escalated patients) or has transitioned from the Open-HART pre-virtualization study period.
- •Willing and able to take oral medication and able to comply with the study specific procedures.
- •Patient has a wireless internet connection at home (and/or applicable locations) at the first remote visit.
- •Patient has the ability to transition from in-person study visits to virtual study visits. The first remote visit (RV1) will take place within approximately 30 days after the last in-person visit.
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •Ongoing treatment with tetrabenazine or deutetrabenazine, seizure threshold lowering medications, or certain antipsychotics and antidepressants.
- •Newly instigated or changed treatment with neuroleptics/antipsychotics
- •Use of tricyclic antidepressants or class I & III antiarrhythmics at any time during the study period.
- •Severe intercurrent illness that, in the opinion of the Investigator (or qualified designee), may put the subject at risk when continuing participation in the study.
- •Alcohol and/or drug abuse as defined by the Diagnostic and Statistical Manual - Fourth Edition - Text Revision criteria for substance abuse - this includes the illicit use of cannabis.
- •Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
- •Females who are pregnant or lactating.
- •Females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
- •Known allergy to any ingredients of the trial medication.
- •Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
pridopidine
Experimental
45mg bid
干预措施: pridopidine (Drug)
结局指标
主要结局
Number of Patients With at Least One Adverse Event
时间窗: From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
次要结局
- Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)(Baseline and at Month 12, 24, 36, 48, 60, and 72)
研究者
相似试验
招募中
2 期
A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast CancerMetastatic Breast CancerJPRN-UMIN000022362Shizuoka Cancer Center48
终止
1 期
First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT05817058Affimed GmbH30
已完成
2 期
Clinical study on AYUARTIS Capsules in OsteoarthritisCTRI/2017/06/008790Welex Laboratories Pvt Ltd31
已完成
2 期
Clinical study of Arthrohills Capsules Arthritis patientsCTRI/2017/06/008786Herbal Hills Ltd33
进行中（未招募）
1 期
First in human study assessing the safety, immunogenicity and efficacy of the cancer vaccine IN01 as second line of treatment in RAS and BRAF mutated metastatic colorectal cancer patientscolorectal cancer at a metastatic stage, eligible for a second line treatment and presenting with a constitutive BRAF or RAS mutationMedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004819-31-BGIN3BIO70