Multiple Sclerosis, Relapsing-RemittingPhase 3NCT00276341
Study on the Effectiveness of EGb 761® vs Placebo Used for Cognitive Impairment in Patients With Multiple Sclerosis
A Phase 3 study testing EGb 761® (Tanakan®) in people with Multiple Sclerosis, Relapsing-Remitting, run by Ipsen at 30 sites in France.
Trial summary
The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- EGb 761® (Tanakan®)
- How many people
- 47 participants
- Where
- 30 sitesFrance
- Study dates
- 26 Aug 2003to 8 Dec 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Multiple Sclerosis Relapsing-Remitting form
- Patient with cognitive impairment (as spontaneous complaint by either patient or family)
- Patient treated with interferon and maintaining same dosage for previous 6 months
- Patient without major disability (Kurtzke Extended Disability Status Scale ≤6)
Who cannot join
- Clinical Multiple Sclerosis relapse within 3 months prior to participation
- Major psychiatric disease according to Diagnostic and Statistical Manual of Mental Disorders, 4th Ed.
- Other concomitant disorders possibly jeopardizing the cognitive status evaluation or the follow up of the patient (severe impairment of visual or motor function which may prevent participation in neuropsychological testing)
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13616
Hôpital Nord - CHU d'Amiens
Amiens, 80054
Hôpital J. Minjoz
Besançon, 25030
CHU de Bordeaux
Bordeaux, 33076
Groupe Hospitalier Pellegrin
Bordeaux, 33076
Hôpital de la cavale Blanche
Brest, 29609
Hôpital Neurologique
Bron, 69500
Hopital Nord
Cébazat, 63118
CHU Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Hôpital Civil de Colmar
Colmar, 68024
Hôpital Henri Mondor
Créteil, 94010
14 bis Rue du Chapeau Rouge
Dijon, 21000
CHG Dijon
Dijon, 21033
Centre Hospitalier
Gonesse, 95503
Hôpital Universitaire Dupuytren
Limoges, 87042
Centre Hospitalier François
Mantes-la-Jolie, 78200
Hôpital Saint Joseph
Marseille, 13008
Hôpital Gui de Chauliac
Montpellier, 34295
Hôpital Central
Nancy, 54035
Hôpital Guillaume et Réne
Nantes, 44093
Hôpital Pasteur
Nice, 06002
Hôpital Léopold Bellan
Paris, 75014
Hôpital Saint Joseph
Paris, 75014
Centre Hospitalier René Dubos
Pontoise, 95303
Hôpital Laënnec
Quimper, 29107
CHU de Reims - Hôpital Maison Blanche
Reims, 51092
CHU Hôpital de Pontchaillou
Rennes, 35033
Hôpital Charles Nicolle
Rouen, 76031
Cabinet Médical
Rouen, 76100
Hôpital Delafontaine
Saint-Denis, 93205
About this study
Official title: Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.
The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- EGb 761® (Tanakan®)
- Keywords
- cognitive impairment
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGb 761® (Tanakan®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
Secondary outcomes (15)
Evolution of the following tests between baseline and week 24:
Multiple Sclerosis Functional Composite Test
Selective Reminding Test
10/36 Visual-Spatial Recall Test
Symbol Digit Modalities Test
Trail Making Test A and B
Verbal Fluency Test
Empan Test
Evolution of the following scales between baseline and week 24:
Cognitive Deficit Interview based screen
Anxiety Brief Scale
Beck Depression Inventory Scale
Modified Fatigue Impact Scale
Evolution of Quality of Life
Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change
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 start26 Aug 2003
- Study completion8 Dec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276341
- Sponsor's protocol ID
- 2-39-00240-126
- Status last verified
- Mar 2024
- First submitted
- 12 Jan 2006
- Last updated
- 7 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.
- ClinicalTrials.gov ID
- NCT00276341
- Acronym / sponsor ID
- 2-39-00240-126
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- cognitive impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2003 (actual)
- Study completion
- 8 Dec 2005 (actual)
- First posted
- 13 Jan 2006 (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 whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with Multiple Sclerosis Relapsing-Remitting form
- Patient with cognitive impairment (as spontaneous complaint by either patient or family)
- Patient treated with interferon and maintaining same dosage for previous 6 months
- Patient without major disability (Kurtzke Extended Disability Status Scale ≤6)
Key exclusion criteria (3 listed)
- Clinical Multiple Sclerosis relapse within 3 months prior to participation
- Major psychiatric disease according to Diagnostic and Statistical Manual of Mental Disorders, 4th Ed.
- Other concomitant disorders possibly jeopardizing the cognitive status evaluation or the follow up of the patient (severe impairment of visual or motor function which may prevent participation in neuropsychological testing)
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 |
|---|---|---|
| EGb 761® (Tanakan®) | Drug | – |
Primary outcome
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
15 secondary outcomes
Evolution of the following tests between baseline and week 24:
Multiple Sclerosis Functional Composite Test
Selective Reminding Test
10/36 Visual-Spatial Recall Test
Symbol Digit Modalities Test
Trail Making Test A and B
Verbal Fluency Test
Empan Test
Evolution of the following scales between baseline and week 24:
Cognitive Deficit Interview based screen
Anxiety Brief Scale
Beck Depression Inventory Scale
Modified Fatigue Impact Scale
Evolution of Quality of Life
Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change
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 7 Mar 2024.
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EGb 761® (Tanakan®) in people with Multiple Sclerosis, Relapsing-Remitting, run by Ipsen at 30 sites in France.
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 4 inclusion and 3 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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. 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.
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?
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?
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24. 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 7 Mar 2024.