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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276380
First received: January 12, 2006
Last updated: July 23, 2009
Last verified: July 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

  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
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, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on September 18, 2014