ISRCTN88122184进行中（未招募）4 期
A randomized, placebo-controlled, double-blind trial to asses the effficacy and safety of CEREBROLYSIN in the treatment of Post-Stroke Cognitive Decline
The foundation for the study of neuroscience and neuroregeneration0 个研究点目标入组 290 人开始时间: 2020年4月29日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 15/07/2021:
- •1. Diagnosis of stroke, ischemic in origin (TACS or PACS), confirmed by MRI
- •2. Onset of Stroke within 72 h prior to screening
- •3. NIH Stroke Scale score between 5-15 at inpatient admission
- •4. Pre-stroke mRS of 0 or 1
- •5. No cognitive impairment prior to stroke with an IQ code score =3
- •6. Aged between 40 and 80 years, inclusive
- •7. Patient is willing and able to comply with the protocol for the duration of the study
- •Previous participant inclusion criteria:
- •1. Acute Ischemic Stroke confirmed by CT
- •2. Stroke is ischemic in origin - TACS or PACS
- •3. Onset of Stroke within 72 hours prior to screening
- •4. NIH Stroke Scale score between 5 and 15
- •5. Pre-stroke mRS of 0 or 1
- •6. No cognitive impairment prior to stroke with an IQ code score < 3
- •7. Age between 40 and 80 years, inclusive
- •8. Diagnosis of stroke ischemic in origin confirmed by MRI
排除标准
- •Current participant exclusion criteria as of 15/07/2021:
- •1. Previous symptomatic ischaemic stroke or intracranial hemorrhage not related to the index stroke
- •2. Severe visual or hearing impairment interfering with psychometric test procedures
- •3. Pre-existing and active major neurological disease (eg. Parkinson’s Disease, Epilepsy)
- •4. Pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- •5. History of significant alcohol or drug abuse
- •6. Advanced liver, kidney, cardiac, or pulmonary disease
- •7. A terminal medical diagnosis with survival <1 year
- •8. Pregnancy or lactating
- •9. Any contraindications to Cerebrolysin
- •10. Current enrolment in another therapeutic study
- •11. Dementia due to strategic index stroke
- •12. Major communication deficits with a Goodglass & Kaplan Score >2
- •13. Aphasia with an NIHSS Item 9 score of =2
- •14. Treatment with Cerebrolysin or Neuroprotectants in the last 30 days
- •15. Severe dementia with MMSE Score <12
- •Previous participant exclusion criteria:
- •1. Previous ischemic stroke or intracranial hemorrhage not related to the index stroke or previous TIA
- •2. Severe visual or hearing impairment interfering with psychometric test procedures
- •3. Pre-existing and active major neurological disease (eg. Parkinson’s Disease, Epilepsy)
- •4. Pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- •5. History of significant alcohol or drug abuse
- •6. Advanced liver, kidney, cardiac, or pulmonary disease
- •7. A terminal medical diagnosis with survival < 1 year
- •8. Pregnancy or lactating
- •9. Any contraindications to Cerebrolysin
- •10. Current enrolment in another therapeutic study
- •11. Dementia due to strategic index stroke
- •12. Major communication deficits with a Goodglass & Kaplan Score > 2
- •13. Aphasia with an NIHSS Item 9 score of > 2
- •14. Treatment with Cerebrolysin or Neuroprotectants in the last 30 days
- •15. Severe dementia with MMSE Score < 12
研究者
相似试验
进行中（未招募）
1 期
A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusActive eosinophilic esophagitisMedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-000082-16-PLEsoCap AG42
进行中（未招募）
1 期
A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusActive eosinophilic esophagitisMedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-000082-16-NLEsoCap AG42
招募中
2 期
A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitischronic inflammation of the esophagus10017969eosinophilic esophagitisNL-OMON52665EsoCap AG10
进行中（未招募）
1 期
A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusEUCTR2020-000082-16-DEEsoCap AG42
已完成
1 期
A placebo-controlled, randomized, double-blind trial to investigate the impact of dapagliflozin on the development of diabetic ketoacidosis and intermediate metabolism in type 1 diabetes using a dual stable tracer method: A safety study investigating the fuel shift theory in the human modelE10Type 1 diabetes mellitusDRKS00021284Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie17