A Phase III, Multicentre, Randomised, Double-blinded, Parallel Group, Placebo Controlled Clinical Study for Evaluating the Efficacy of EGb 761® (Tanakan®) (240mg) in the Recovery of Neurological Impairment Following Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 204
- 试验地点
- 10
- 主要终点
- Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having had a single infarct in the carotid artery territory 3 to 8 days before inclusion
- •Patient with a moderately severe or severe disability (Modified Rankin Score 4 or 5)
- •Patient having a Quick's Test (for INR) and APPT (activated partial prothrombin time) test in the normal values of the laboratory
排除标准
- •Patients having had an ischemic stroke (CT confirmed) less than 3 days and more than 8 days prior
- •Patient with known pre-existent cerebral infarction
- •Infarct damaged area bigger than 1/3 hemisphere
- •Patient having a score below the cut-off point at Frenchay Aphasia Short Test
研究组 & 干预措施
EGb761®
EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consists of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
干预措施: EGb761 (Drug)
EGb761®
EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consists of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
干预措施: Acetylsalicylic acid (Drug)
Placebo
6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
干预措施: Placebo (Drug)
Placebo
6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.
时间窗: Day 168
The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score\<3 at the end of the study (Day 168) are reported.
次要结局
- Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.(Up to Day 168)
- Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.(Up to Day 168)
- Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.(Up to Day 168)
- Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.(Up to Day 168)
- Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.(Up to Day 84)
- Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168.(Up to Day 168)