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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

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 Drug: Placebo Drug: Acetylsalicylic acid Phase 3

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
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: EGb761®

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

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

Drug: EGb761
EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.
Other Name: Tanakan
Drug: Acetylsalicylic acid
Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
Placebo Comparator: Placebo

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

The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.

Drug: Placebo
Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.
Drug: Acetylsalicylic acid
Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.



Primary Outcome Measures :
  1. Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. [ Time Frame: Day 168 ]
    The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at the end of the study (Day 168) are reported.


Secondary Outcome Measures :
  1. Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. [ Time Frame: Up to Day 84 ]
    The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at each follow-up visit (not including end of study) are reported.

  2. 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 ]
    The degree of disability and dependence in daily activities was assessed using the modified Rankin scale.The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability,3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The distribution of subjects according to disability severity scores was assessed and the percentage of subjects at each point on the modified Rankin scale are reported for each time point.

  3. 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 ]
    The SCAG scale was to be used to evaluate the psychopathological state of the subject. It is composed of 18 symptom areas and an overall global assessment, all rated on a 7-point format from 1=not present to 7=severe. The total score range is from 19 to 133 (best to worst), with a negative mean change from baseline indicating an improvement in symptoms. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.

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

    The performance in activities of daily living was assessed by using the Barthel scale. The Barthel scale is an ordinal scale which measures 10 performance items describing activities of daily living. Each item is rated with a given number of points from 0 indicating total dependence up to a maximum of 10 or 15 (depending on performance item) indicating complete independence. The total score range is from 0 to 100 (worst to best), with a positive mean change indicating an improvement in independence.

    Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.


  5. 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 ]
    The MMS test was used to evaluate the cognitive function of the subject. It includes tests of orientation, attention, memory, language and visual spatial skills, which are rated with a given number of points assigned to each level or ranking. The lower the score, the more important the mental deficit. The total score range is from 0 to 30 (worst to best), with a positive mean change indicating an improvement (i.e. less mental deficit). Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.

  6. 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 ]

    The NIHSS was to be used to objectively quantify the impairment caused by the stroke.The NIHSS is composed of 11 items, each of which score a specific ability between 0 (normal function) and 4 (high level of impairment).The minimum total score is 0 and maximum is 42. Only 8 of the NIHSS subscores were calculated for this study.

    Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. Mean NIHSS subscores for questions 1a (level of consciousness),1b (asking patient the month and their age), and 1c (asking to open and close eyes) were analysed using descriptive quantitative statistics at each visit and the mean change from baseline at each time point is reported. The range for the subscore for items 1a is 0 - 3, for 1b is 0 - 2 and for 1c is 0 - 2 (best to worst), with a negative mean change from baseline indicating an improvement.




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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

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
Czechia
Faculty of Medicine in Hradec Kralove
Hradec Kralove, Czechia, 500 02
General Faculty Hospital
Prague 2, Czechia, 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

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
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018
Last Verified: February 2018
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