Status:
COMPLETED
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
Lead Sponsor:
Ipsen
Conditions:
Stroke, Acute
Neurological Impairment
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00276380
Start Date
February 1 2003
End Date
March 1 2009
Last Update
January 8 2019
Active Locations (10)
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1
Faculty of Medicine in Hradec Kralove
Hradec Králové, Czechia, 500 02
2
General Faculty Hospital
Prague, Czechia, 120 00
3
Department and Clinic of Neurology of the Old Age
Katowice, Poland, 40 752
4
CMUJ Krakov
Krakow, Poland, 31503