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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
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.
Details
| Lead sponsor | Ipsen |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 204 |
| Start date | 2003-02 |
| Completion | 2009-03 |
Conditions
- Stroke, Acute
- Neurological Impairment
Interventions
- EGb761
- Placebo
- Acetylsalicylic acid
Primary outcomes
- Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. — 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.
Countries
Czechia, Poland, Romania, Russia