We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00276380
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Neurological Impairment Drug: EGb761 (Tanakan) and acetylsalicylic acid Drug: Placebo and acetylsalicylic acid Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2003
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 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
Placebo Comparator: 2 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


Outcome Measures

Primary Outcome Measures :
  1. Patients with Modified Rankin score 0 or 1 or 2 at the end of study period. [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276380


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

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00276380     History of Changes
Other Study ID Numbers: A-38-00240-704
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Neurologic Manifestations
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics