Clinical trial NCT00276380: A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke, Acute
Neurological Impairment
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 204
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.
timeFrame: Day 168
Secondary outcomes:
measure: Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.
timeFrame: Up to Day 84
measure: Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
timeFrame: Up to Day 168
measure: Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.
timeFrame: Up to Day 168
measure: Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.
timeFrame: Up to Day 168
measure: Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.
timeFrame: Up to Day 168
measure: 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.
timeFrame: Up to Day 168
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: Faculty of Medicine in Hradec Kralove
city: Prague 2
country: Czechia
facility: General Faculty Hospital
city: Katowice
country: Poland
facility: Department and Clinic of Neurology of the Old Age
city: Krakov
country: Poland
facility: CMUJ Krakov
city: Warsaw
country: Poland
facility: Postgraduate Medical Teaching Center
city: Bucharest
country: Romania
facility: Institul de Boli Cerebro Vascular
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta
city: Moscow
country: Russian Federation
facility: Russian State Medical University - Neurology and Neurosurgery Clinic
city: Moscow
country: Russian Federation
facility: Russian State Medical University - Dept Fundamental Neurology & Neurosurgery
city: Yekaterinburg
country: Russian Federation
facility: Ural State Medical Academy
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: