Neurological Impairment, Stroke, Acute
Conditions
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.
Interventions
DRUGEGb761
EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.
DRUGPlacebo
Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.
DRUGAcetylsalicylic acid
Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | 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. |
| Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | 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. |
| Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. | 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. |
| Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | 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. |
| 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. | 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. |
| Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | 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. |
Countries
Czechia, Poland, Romania, Russia
Participant flow
Recruitment details
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
The inclusion (baseline) visit on Day 0 was to take place within 3-8 days following an ischaemic stroke.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| 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 | 102 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal aPPT Levels | 0 | 1 |
| Overall Study | Adverse Event | 5 | 3 |
| Overall Study | Death | 5 | 3 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | EGb761® | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 69 years | 68 years |
| Sex: Female, Male Female | 35 Participants | 47 Participants | 82 Participants |
| Sex: Female, Male Male | 67 Participants | 55 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 101 | 3 / 100 |
| other Total, other adverse events | 16 / 101 | 17 / 100 |
| serious Total, serious adverse events | 12 / 101 | 7 / 100 |
Outcome results
Primary
Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.
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.
Time frame: Day 168
Population: This analysis was performed on the Intention-To-Treat (ITT) population which includes all subjects having at least one treatment dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EGb761® | Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. | 59.8 percentage of participants |
| Placebo | Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. | 64.7 percentage of participants |
Comparison: The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.p-value: 0.5295% CI: [0.46, 1.48]Cochran-Mantel-Haenszel
Secondary
Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and 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.
Time frame: Up to Day 168
Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EGb761® | Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | Day 28 | 31.2 units on a scale | Standard Deviation 20.3 |
| EGb761® | Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | Day 84 | 40.1 units on a scale | Standard Deviation 19.9 |
| EGb761® | Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | Day 168 | 46.3 units on a scale | Standard Deviation 20.5 |
| Placebo | Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | Day 28 | 30.6 units on a scale | Standard Deviation 18.6 |
| Placebo | Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | Day 84 | 41.5 units on a scale | Standard Deviation 19.3 |
| Placebo | Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168. | Day 168 | 45.9 units on a scale | Standard Deviation 19.2 |
Comparison: Comparison of treatment effect at Day 28p-value: 0.24ANCOVA
Comparison: Comparison of treatment effect at Day 84p-value: 0.441ANCOVA
Comparison: Comparison of treatment effect at Day 168p-value: 0.645ANCOVA
Secondary
Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and 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.
Time frame: Up to Day 168
Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EGb761® | Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | Day 28 | -7.3 units on a scale | Standard Deviation 5.9 |
| EGb761® | Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | Day 84 | -8.8 units on a scale | Standard Deviation 8.7 |
| EGb761® | Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | Day 168 | -11.7 units on a scale | Standard Deviation 8.2 |
| Placebo | Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | Day 28 | -5.0 units on a scale | Standard Deviation 5.3 |
| Placebo | Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | Day 84 | -7.1 units on a scale | Standard Deviation 6.6 |
| Placebo | Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168. | Day 168 | -9.2 units on a scale | Standard Deviation 6.6 |
Comparison: Comparison of treatment effect at Day 28p-value: 0.207ANCOVA
Comparison: Comparison of treatment effect at Day 84p-value: 0.59ANCOVA
Comparison: Comparison of treatment effect at Day 168p-value: 0.814ANCOVA
Secondary
Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and 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.
Time frame: Up to Day 168
Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EGb761® | Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | Day 28 | 1.2 units on a scale | Standard Deviation 1.9 |
| EGb761® | Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | Day 84 | 1.4 units on a scale | Standard Deviation 2.3 |
| EGb761® | Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | Day 168 | 1.9 units on a scale | Standard Deviation 2.7 |
| Placebo | Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | Day 28 | 1.2 units on a scale | Standard Deviation 1.6 |
| Placebo | Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | Day 84 | 1.7 units on a scale | Standard Deviation 2.3 |
| Placebo | Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168. | Day 168 | 2.0 units on a scale | Standard Deviation 2.6 |
Comparison: Comparison of treatment effect at Day 28p-value: 0.623ANCOVA
Comparison: Comparison of treatment effect at Day 84p-value: 0.338ANCOVA
Comparison: Comparison of treatment effect at Day 168p-value: 0.828ANCOVA
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.
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.
Time frame: Up to Day 168
Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EGb761® | 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. | Day 28 | -0.0 units on a scale | Standard Deviation 0.2 |
| EGb761® | 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. | Day 84 | -0.0 units on a scale | Standard Deviation 0.2 |
| EGb761® | 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. | Day 168 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | 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. | Day 28 | -0.0 units on a scale | Standard Deviation 0.2 |
| Placebo | 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. | Day 84 | -0.0 units on a scale | Standard Deviation 0.1 |
| Placebo | 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. | Day 168 | -0.0 units on a scale | Standard Deviation 0.2 |
Secondary
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and 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.
Time frame: Up to Day 168
Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: No symptoms at all | 1.0 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: No significant disability | 0 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Slight disability | 0 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Moderate disability | 0 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Moderately severe disability | 74.5 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Severe disability | 25.5 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: No symptoms at all | 0 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: No significant disability | 7.2 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Slight disability | 24.7 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Moderate disability | 38.1 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Moderately severe disability | 26.8 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Severe disability | 2.1 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: No symptoms at all | 5.4 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: No significant disability | 24.7 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Slight disability | 20.4 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Moderate disability | 38.7 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Moderately severe disability | 10.8 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Severe disability | 0.0 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: No symptoms at all | 12.5 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: No significant disability | 29.5 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Slight disability | 27.3 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Moderate disability | 25.0 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Moderately severe disability | 5.7 percentage of participants |
| EGb761® | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Severe disability | 0.0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Moderately severe disability | 6.8 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: No symptoms at all | 0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: No symptoms at all | 5.6 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: No significant disability | 0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: No symptoms at all | 17.0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Slight disability | 0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: No significant disability | 25.8 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Moderate disability | 0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Moderate disability | 20.5 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Moderately severe disability | 70.6 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Slight disability | 28.1 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 0: Severe disability | 29.4 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: No significant disability | 31.8 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: No symptoms at all | 1.0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Moderate disability | 27.0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: No significant disability | 9.4 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Severe disability | 0.0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Slight disability | 27.1 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Moderately severe disability | 13.5 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Moderate disability | 31.3 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 168: Slight disability | 23.9 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Moderately severe disability | 27.1 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 84: Severe disability | 0.0 percentage of participants |
| Placebo | Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168. | Day 28: Severe disability | 4.2 percentage of participants |
Secondary
Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and 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.
Time frame: Up to Day 84
Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EGb761® | Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. | Day 28 | 31.4 percentage of participants |
| EGb761® | Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. | Day 84 | 46.1 percentage of participants |
| Placebo | Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. | Day 28 | 35.3 percentage of participants |
| Placebo | Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84. | Day 84 | 53.9 percentage of participants |
Comparison: The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.p-value: 0.62395% CI: [0.47, 1.57]Cochran-Mantel-Haenszel
Comparison: The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.p-value: 0.395% CI: [0.42, 1.3]Cochran-Mantel-Haenszel