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

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ClinicalTrials.gov Identifier: NCT00276380
Recruitment Status : Completed
First Posted : January 13, 2006
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Stroke, Acute
Neurological Impairment
Interventions: Drug: EGb761
Drug: Placebo
Drug: Acetylsalicylic acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a multicentre, international, randomised, double-blind, placebo-controlled study in which 204 subjects were enrolled in 8 centres, distributed in 4 countries: Romania, Poland, Czech Republic and Russian Federation, from 20 February 2003 to 25 February 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The inclusion (baseline) visit on Day 0 was to take place within 3-8 days following an ischaemic stroke.

Reporting Groups
  Description
EGb761®

Subjects received EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).

The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.

Placebo

Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).

The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.


Participant Flow:   Overall Study
    EGb761®   Placebo
STARTED   102   102 
COMPLETED   88   88 
NOT COMPLETED   14   14 
Adverse Event                5                3 
Lost to Follow-up                1                1 
Withdrawal by Subject                3                6 
Death                5                3 
Abnormal aPPT Levels                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
EGb761®

Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).

The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.

Placebo

Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).

The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch

Total Total of all reporting groups

Baseline Measures
   EGb761®   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 102   102   204 
Age 
[Units: Years]
Median (Full Range)
 68 
 (50 to 83) 
 69 
 (50 to 90) 
 68 
 (50 to 90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      35  34.3%      47  46.1%      82  40.2% 
Male      67  65.7%      55  53.9%      122  59.8% 


  Outcome Measures

1.  Primary:   Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.   [ Time Frame: Day 168 ]

2.  Secondary:   Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.   [ Time Frame: Up to Day 84 ]

3.  Secondary:   Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.   [ Time Frame: Up to Day 168 ]

4.  Secondary:   Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.   [ Time Frame: Up to Day 168 ]

5.  Secondary:   Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.   [ Time Frame: Up to Day 168 ]

6.  Secondary:   Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.   [ Time Frame: Up to Day 168 ]

7.  Secondary:   Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168.   [ Time Frame: Up to Day 168 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Ipsen
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00276380     History of Changes
Other Study ID Numbers: A-38-00240-704
First Submitted: January 12, 2006
First Posted: January 13, 2006
Results First Submitted: March 27, 2017
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018