Phase 3
N=204
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
Stroke, Acute · Neurological Impairment
Bottom Line
View on ClinicalTrials.gov: NCT00276380 ↗Enrolled (actual)
204
Serious AEs
9.5%
Results posted
Feb 2018
Primary outcome: Primary: Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. — 59.8; 64.7 percentage of participants — p=0.52
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- EGb761 (Drug); Placebo (Drug); Acetylsalicylic acid (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. |
59.8; 64.7 | 0.52 |
| SECONDARY Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. |
31.4; 35.3; 46.1; 53.9 | 0.623 |
| SECONDARY Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. |
-7.3; -5.0; -8.8; -7.1; -11.7; -9.2 | 0.207 |
| SECONDARY Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. |
31.2; 30.6; 40.1; 41.5; 46.3; 45.9 | 0.240 |
| SECONDARY Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. |
1.2; 1.2; 1.4; 1.7; 1.9; 2.0 | 0.623 |
| SECONDARY 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. |
-0.0; -0.0; -0.0; -0.0; -0.0; -0.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00276380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.