Cognitive DisordersTAYPESNCT02321475
EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders
An observational study of Cognitive Disorders, run by Ipsen at 2 sites in Russia.
Trial summary
The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood test) score. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cognitive Disorders
- What is being tested?
- EGb761®
- How many people
- 54 participants
- Where
- 2 sitesRussia
- Study dates
- Jun 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Middle-age or younger patients with cognitive disorders and psycho-emotional symptoms (principal diagnosis).
Who may be able to join
- Patients who signed the Informed Consent for participation in the observational study before collection of any information
- Patients who complain of psycho-emotional disturbance (of any intensity)
- Men and women aged 18-45 years, who prescribed to receive Tanakan® for cognitive disorders
Who cannot join
- Presence of any contraindications listed in the Tanakan® local SmPC (hypersensitivity to any of the components of Tanakan®, pregnancy, lactation, erosive gastritis in acute phase, gastric ulcer and duodenum ulcer in acute phase, acute cerebrovascular accident, acute myocardial infarction, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption, haemolysis)
- Presence of dementia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM IV])
- Disturbance of usual activities of daily living (e.g. self-care)
- Patients taking antipsychotic drugs, antidepressants, tranquillisers and nootropic agents
- Presence of any severe disease or condition which could affect cognitive function (e.g. Parkinson disease, epilepsy, brain inflammatory disease, major depression, recent post-stroke condition, recent brain-trauma etc.);
- Presence of anxiety or depression according to the Hospital Anxiety and Depression Scale (11 points and more).
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Russian National Research Medical University
Moscow, 117152
First Moscow State Medical University
Moscow, 119435
About this study
Official title: Non-interventional Prospective Observational Study to Describe EGB 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders.
The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood test) score.
- Conditions
- Cognitive Disorders
- Being tested
- EGb761®
- Keywords
- Psycho-emotional symptoms
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGb761®Drug
Also called Tanakan®
| Study group | Role | What they receive |
|---|---|---|
| Psycho-emotional symptoms, added to cognitive disorders | Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders. Receives: Drug: EGb761® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment
The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated.
Measured: 3 months
Secondary outcomes (4)
Change from baseline of total medium FAM test score.
The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated.
Measured: 3 months
Change from baseline of short-time verbal memory
Investigator to assess short-time verbal memory using a set 10-words recall test.
Measured: 3 months
Change from baseline of attention
Attention assessed using a digit-symbol coding test. The digit symbol score is the percentage of correct symbols completed in 90 seconds.
Measured: 3 months
Percentage of patients who answered "Completely satisfied", "Rather satisfied", "Neither satisfied nor dissatisfied", "Rather dissatisfied" or "Completely dissatisfied", when assessing their satisfaction with Tanakan®
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisordersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 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
- NCT02321475
- Sponsor's protocol ID
- A-38-00240-138
- Acronym
- TAYPES
- Status last verified
- Mar 2020
- First submitted
- 17 Dec 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Prospective Observational Study to Describe EGB 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders.
- ClinicalTrials.gov ID
- NCT02321475
- Acronym / sponsor ID
- TAYPES / A-38-00240-138
- Conditions
- Cognitive Disorders
- Keywords
- Psycho-emotional symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
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 determine the effectiveness of EGb 761® (Tanakan®) in Russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood test) score.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psycho-emotional symptoms, added to cognitive disorders | – | Drug: EGb761®Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Middle-age or younger patients with cognitive disorders and psycho-emotional symptoms (principal diagnosis).
Key inclusion criteria (3 listed)
- Patients who signed the Informed Consent for participation in the observational study before collection of any information
- Patients who complain of psycho-emotional disturbance (of any intensity)
- Men and women aged 18-45 years, who prescribed to receive Tanakan® for cognitive disorders
Key exclusion criteria (6 listed)
- Presence of any contraindications listed in the Tanakan® local SmPC (hypersensitivity to any of the components of Tanakan®, pregnancy, lactation, erosive gastritis in acute phase, gastric ulcer and duodenum ulcer in acute phase, acute cerebrovascular accident, acute myocardial infarction, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption, haemolysis)
- Presence of dementia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM IV])
- Disturbance of usual activities of daily living (e.g. self-care)
- Patients taking antipsychotic drugs, antidepressants, tranquillisers and nootropic agents
- Presence of any severe disease or condition which could affect cognitive function (e.g. Parkinson disease, epilepsy, brain inflammatory disease, major depression, recent post-stroke condition, recent brain-trauma etc.);
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 |
|---|---|---|
| EGb761®Also: Tanakan® | Drug | Psycho-emotional symptoms, added to cognitive disorders |
Primary outcome
Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment
Time frame: 3 months
The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated.
4 secondary outcomes
Change from baseline of total medium FAM test score.
Time frame: 3 months
Change from baseline of short-time verbal memory
Time frame: 3 months
Change from baseline of attention
Time frame: 3 months
Percentage of patients who answered "Completely satisfied", "Rather satisfied", "Neither satisfied nor dissatisfied", "Rather dissatisfied" or "Completely dissatisfied", when assessing their satisfaction with Tanakan®
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Disorders, run by Ipsen at 2 sites in Russia.
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 6 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients with increase of total medium FAM test score ≥1 after 3 months treatment (time frame: 3 months). 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 31 Mar 2020.