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

January 12, 2006
July 23, 2009
February 2003
March 2009   (final data collection date for primary outcome measure)
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 ]
Patients with Modified Rankin score 0 or 1 or 2 at the end of study period (Month 6)
Complete list of historical versions of study NCT00276380 on ClinicalTrials.gov Archive Site
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 ]
Evolution of the following scores and scales: Barthel index, Modified Rankin score, National Institutes of Health Score Scale, Sandoz Scale, Mini Mental State
Not Provided
Not Provided
 
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Stroke, Acute
  • Neurological Impairment
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: EGb761 (Tanakan) and acetylsalicylic acid
  • Placebo Comparator: 2
    Intervention: Drug: Placebo and acetylsalicylic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Poland,   Romania,   Russian Federation
 
NCT00276380
A-38-00240-704
Not Provided
Stefan Lempereur, Ipsen
Ipsen
Not Provided
Study Director: Stefan Lempereur, MD Ipsen
Ipsen
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP