Stroke, AcutePhase 3NCT00276380
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
A Phase 3 study testing EGb761 and Acetylsalicylic acid in people with Stroke, Acute and Neurological Impairment, run by Ipsen at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Acute, Neurological Impairment
- What is being tested?
- EGb761 and Acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Feb 2003to Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Poland3 sites
Department and Clinic of Neurology of the Old Age
Katowice, 40 752
CMUJ Krakov
Krakow, 31503
Postgraduate Medical Teaching Center
Warsaw, 00 416
Russia3 sites
Russian State Medical University - Neurology and Neurosurgery Clinic
Moscow, 117415
Russian State Medical University - Dept Fundamental Neurology & Neurosurgery
Moscow, 129327
Ural State Medical Academy
Yekaterinburg, 620102
Czechia2 sites
Faculty of Medicine in Hradec Kralove
Hradec Králové, 500 02
General Faculty Hospital
Prague, 120 00
Romania2 sites
Institul de Boli Cerebro Vascular
Bucharest, 75622
Spitalul Universitar de Urgenta
Bucharest, Sector 5
About this study
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
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.
- Conditions
- Stroke, Acute, Neurological Impairment
- Being tested
- EGb761, Placebo, Acetylsalicylic acid
- Medical subject headings
- Stroke, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGb761Drug
Also called Tanakan
EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.
PlaceboDrug
Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.
Acetylsalicylic acidDrug
Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| EGb761® | Experimental | 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. Receives: Drug: EGb761; Drug: Acetylsalicylic acid |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 168
Secondary outcomes (6)
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.
Measured: Up to Day 84
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.
Measured: Up to Day 168
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.
Measured: Up to Day 168
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.
Measured: Up to Day 168
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.
Measured: Up to Day 168
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.
Measured: Up to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startFeb 2003
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276380
- Sponsor's protocol ID
- A-38-00240-704
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2006
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00276380
- Acronym / sponsor ID
- A-38-00240-704
- Conditions
- Stroke, Acute, Neurological Impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGb761® | Experimental | Drug: EGb761, Drug: Acetylsalicylic acidEGb761® 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Acetylsalicylic acid6 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGb761Also: TanakanEGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months. | Drug | EGb761® |
| PlaceboPlacebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months. | Drug | Placebo |
| Acetylsalicylic acidAcetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months. | Drug | EGb761®, Placebo |
Primary outcome
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.
6 secondary outcomes
Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.
Time frame: Up to Day 84
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
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
Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.
Time frame: Up to Day 168
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EGb761 and Acetylsalicylic acid in people with Stroke, Acute and Neurological Impairment, run by Ipsen at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland, Russia, Czechia, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period. (time frame: Day 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.