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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Neurological Impairment; Stroke, Acute

Treatments: Drug: Acetylsalicylic acid; Drug: Placebo; Drug: EGb761

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276380

A-38-00240-704

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups, including a placebo group

EGb761®

Experimental group

Description:

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.

Treatment:

Drug: EGb761

Drug: Acetylsalicylic acid

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Acetylsalicylic acid

Drug: Placebo