A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00276380

Purpose

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.

Condition	Intervention	Phase
Stroke, Acute Neurological Impairment	Drug: EGb761 (Tanakan) and acetylsalicylic acid Drug: Placebo and acetylsalicylic acid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid EGB 761

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Patients with Modified Rankin score 0 or 1 or 2 at the end of study period. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evolution of the following scores and scales: Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	204
Study Start Date:	February 2003
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: EGb761 (Tanakan) and acetylsalicylic acid EGb761 (Tanakan) 40mg tablets (2 tablets tid) 240mg/day AND acetylsalicylic acid (1 tablet once daily), 325 mg/day, for 6 months
2: Placebo Comparator	Drug: Placebo and acetylsalicylic acid Placebo 40 mg tablets (2 tablets tid) AND acetylsalicylic acid, 325 mg/day (1 tablet once daily) for 6 months

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276380

Locations

Czech Republic
General Faculty Hospital
Prague 2, Czech Republic, 120 00
Faculty of Medicine in Hradec Kralove
Hradec Kralove, Czech Republic, 500 02
Poland
CMUJ Krakov
Krakov, Poland, 31503
Postgraduate Medical Teaching Center
Warsaw, Poland, 00 416
Department and Clinic of Neurology of the Old Age
Katowice, Poland, 40 752
Romania
Spitalul Universitar de Urgenta
Bucharest, Romania, Sector 5
Institul de Boli Cerebro Vascular
Bucharest, Romania, 75622
Russian Federation
Russian State Medical University - Neurology and Neurosurgery Clinic
Moscow, Russian Federation, 117415
Ural State Medical Academy
Yekaterinburg, Russian Federation, 620102
Russian State Medical University - Dept Fundamental Neurology & Neurosurgery
Moscow, Russian Federation, 129327

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Stefan Lempereur, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Stefan Lempereur )
Study ID Numbers:	A-38-00240-704
Study First Received:	January 12, 2006
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00276380 History of Changes
Health Authority:	Romania: National Medicines Agency; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Neurologic Manifestations
Platelet Aggregation Inhibitors
Brain Infarction
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010