A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke, Acute Neurological Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

EGb761

Intervention Type DRUG

EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.

Acetylsalicylic acid

Intervention Type DRUG

Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.

Acetylsalicylic acid

Intervention Type DRUG

Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.

Interventions

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EGb761

EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.

Intervention Type DRUG

Placebo

Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.

Intervention Type DRUG

Acetylsalicylic acid

Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.

Intervention Type DRUG

Other Intervention Names

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Tanakan

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No