Multiple SclerosisNCT01084798
A Retrospective Study to Understand the Clinical Management of Subjects With Multiple Sclerosis at a Site in Taiwan Over the Last 10 Years
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in Taiwan.
Trial summary
This is an observational, non comparative, non-randomised, open-label, retrospective, single centre study planned to collect the data of subjects diagnosed with multiple sclerosis (MS) as per Poser or McDonald criteria between 1997 and 2007 in Taiwan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 123 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Nov 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects diagnosed with MS between 1997 and 2007 in Taiwan
Who may be able to join
- Subjects diagnosed with MS as per Poser or McDonald criteria between 1997 and 2007
- EDSS before treatment was available if subject has started the disease modifying drug treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study On The Management of Multiple Sclerosis (MS) Over The Last 10 Years
This is an observational, non comparative, non-randomised, open-label, retrospective, single centre study planned to collect the data of subjects diagnosed with multiple sclerosis (MS) as per Poser or McDonald criteria between 1997 and 2007 in Taiwan. The clinical features and annual relapse rate in the first five years after the onset of disease have been compared between conventional and optico-spinal MS in the earlier studies. This study aims to understand the clinical care pathway of MS subjects and facilitate the subject's diagnosis before converting to MS.
Read the detailed description
Multiple Sclerosis is a chronic, inflammatory disease of the central nervous system (CNS) and is characterised by areas of demyelination, or plaques in the CNS. The disease is twice as prevalent in women as compared to men and causes considerable disability over time and continues for the lifetime of the subject. Subjects with MS are thought to have a genetic predisposition for the disease, though environmental factors such as geographic location and possibly viral infection also play an important role in the process of development of the disease.
OBJECTIVES
Primary objective:
- To understand the clinical care pathways of MS subjects at the site over the last 10 years in order to raise the medical attention of MS diagnosis
Secondary objective:
- To review the pattern of MS treatment regimens in MS subjects at a particular site between 1997 and 2007
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Expanded Disability Status Scale, Sclerosis
- Medical subject headings
- Multiple Sclerosis, Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of locations (medical centre, regional hospital, general practitioners) where subjects were treated for the first episode of attack prior to multiple sclerosis diagnosis
Measured: Data collected for last 10 years between 1997 and 2007
Secondary outcomes (6)
Duration from first attack to confirmation of MS
Measured: Data collected for last 10 years between 1997 and 2007
Distribution of MS diagnosis criteria and treatment regimens
Measured: Data collected for last 10 years between 1997 and 2007
Annual relapse rate before and after MS treatment
Measured: Data collected for last 10 years between 1997 and 2007
Changes in Expanded Disability Status Scale (EDSS) before and after treatment
Measured: Data collected for last 10 years between 1997 and 2007
Changes in VEP before and after treatment
Measured: Data collected for last 10 years between 1997 and 2007
Association between baseline demographics/disease characteristics and MS
Measured: Data collected for last 10 years between 1997 and 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084798
- Sponsor's protocol ID
- EMR 200077-503
- Status last verified
- Mar 2010
- First submitted
- 10 Mar 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study On The Management of Multiple Sclerosis (MS) Over The Last 10 Years
- ClinicalTrials.gov ID
- NCT01084798
- Acronym / sponsor ID
- EMR 200077-503
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Expanded Disability Status Scale, Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Mar 2010 (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.
This is an observational, non comparative, non-randomised, open-label, retrospective, single centre study planned to collect the data of subjects diagnosed with multiple sclerosis (MS) as per Poser or McDonald criteria between 1997 and 2007 in Taiwan. The clinical features and annual relapse rate in the first five years after the onset of disease have been compared between conventional and optico-spinal MS in the earlier studies. This study aims to understand the clinical care pathway of MS subjects and facilitate the subject's diagnosis before converting to MS.
Detailed description
Multiple Sclerosis is a chronic, inflammatory disease of the central nervous system (CNS) and is characterised by areas of demyelination, or plaques in the CNS. The disease is twice as prevalent in women as compared to men and causes considerable disability over time and continues for the lifetime of the subject. Subjects with MS are thought to have a genetic predisposition for the disease, though environmental factors such as geographic location and possibly viral infection also play an important role in the process of development of the disease.
OBJECTIVES
Primary objective:
- To understand the clinical care pathways of MS subjects at the site over the last 10 years in order to raise the medical attention of MS diagnosis
Secondary objective:
- To review the pattern of MS treatment regimens in MS subjects at a particular site between 1997 and 2007
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects diagnosed with MS between 1997 and 2007 in Taiwan
Key inclusion criteria (2 listed)
- Subjects diagnosed with MS as per Poser or McDonald criteria between 1997 and 2007
- EDSS before treatment was available if subject has started the disease modifying drug treatment.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of locations (medical centre, regional hospital, general practitioners) where subjects were treated for the first episode of attack prior to multiple sclerosis diagnosis
Time frame: Data collected for last 10 years between 1997 and 2007
6 secondary outcomes
Duration from first attack to confirmation of MS
Time frame: Data collected for last 10 years between 1997 and 2007
Distribution of MS diagnosis criteria and treatment regimens
Time frame: Data collected for last 10 years between 1997 and 2007
Annual relapse rate before and after MS treatment
Time frame: Data collected for last 10 years between 1997 and 2007
Changes in Expanded Disability Status Scale (EDSS) before and after treatment
Time frame: Data collected for last 10 years between 1997 and 2007
Changes in VEP before and after treatment
Time frame: Data collected for last 10 years between 1997 and 2007
Association between baseline demographics/disease characteristics and MS
Time frame: Data collected for last 10 years between 1997 and 2007
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 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in Taiwan.
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 2 inclusion and 0 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Distribution of locations (medical centre, regional hospital, general practitioners) where subjects were treated for the first episode of attack prior to multiple sclerosis diagnosis (time frame: Data collected for last 10 years between 1997 and 2007). 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 Jul 2014.