A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00276380
First received: January 12, 2006
Last updated: July 23, 2009
Last verified: July 2009
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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
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 May 16, 2013