Multiple SclerosisNEONCT01112657
An Observational Study on the Progression of Clinically Isolated Syndrome to Multiple Sclerosis Over a 2-year Period
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 6 sites in Taiwan.
Trial summary
This is a prospective, multicentric, observational study with a 2 years recruitment period. The purpose of the study is to observe the multiple sclerosis (MS) progression of subjects since their first episode of neurological event and secondly, to determine status of anti-AQP4 immunoglobulin (IgG) antibody in MS… Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 154 participants
- Where
- 6 sitesTaiwan
- Study dates
- Nov 2008to Oct 2014
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects who have experienced a single, first clinical event potentially suggestive of MS within the last 2 years from study entry.
Who may be able to join
- Subjects aged between 6-60 years, both inclusive
- Subjects who have experienced a single, first clinical event potentially suggestive of MS within the last 2 years from study entry. The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic, other than paresthesia or vegetative dysfunction
- Subjects who have given written informed consent.
Who cannot join
- Subjects with the diagnosis of MS
- Subjects with other disease that could better explain the subject's signs and symptoms
- Subjects who are scheduled to participate in any interventional treatment trial
- Subjects who have any condition that could interfere with MRI evaluation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Kaohsiung Medical University, Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chang-Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, 833
China Medical University Hospital
Taichung, 404
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 201
Chang-Gung Memorial Hospital - Linkou Branch
Taoyuan, 333
About this study
Official title: A Prospective, Observational Study On The Progression Of Clinically Isolated Syndrome (CIS) To Multiple Sclerosis Over A 2-year Period
This is a prospective, multicentric, observational study with a 2 years recruitment period. The purpose of the study is to observe the multiple sclerosis (MS) progression of subjects since their first episode of neurological event and secondly, to determine status of anti-AQP4 immunoglobulin (IgG) antibody in MS subjects.
Read the detailed description
Multiple sclerosis is chronic, inflammatory disease of the central nervous system (CNS) characterised by areas of demyelination, or plaques, in the CNS. In 85% of subjects who later develop MS, clinical onset is with an acute or subacute episode of neurological disturbance due to a single white-matter lesion (e.g. optic neuritis, or an isolated brainstem or partial spinal-cord syndrome). This presentation is known as a Clinically Isolated Syndrome (CIS). Because a CIS is typically the earliest clinical expression of MS, research on subjects with a CIS may provide new insights into early pathological changes and pathogenetic mechanisms that might affect the course of the disorder.
In the group of subjects with optic-spinal MS (OSMS), the main lesions are typically confined to the optic nerve and spinal cord. In Asians, OSMS has similar features to the relapsing remitting form of neuromyelitis optica (NMO) seen in Westerners. It is still a matter of debate whether NMO represents a disease entity in itself or whether it is a subform of MS. Early differentiation of NMO from MS is highly desirable, as treatment options and prognoses differ widely. Recently, a new serum autoantibody (NMO-IgG) has been detected in NMO subjects. The binding sites of this autoantibody were reported to colocalize with aquaporin 4 (AQP4) water channels. Optic-spinal MS is sometime suggested to be NMO based on the frequent detection of the anti-AQP4 IgG antibody. In Taiwan, study has shown that 56% of MS subjects were of the optic-spinal type.
OBJECTIVES
The study is designed firstly, to observe the MS progression of subjects since their first episode of neurological event and secondly, to determine status of anti-AQP4 IgG antibody in MS subjects.
Primary objective:
- To describe the progression of subjects who have experienced a CIS to MS over a 2-year period
Secondary objectives:
- To assess the relationship between CIS and MS including optic-spinal MS (OSMS)
- To determine the status of anti-AQP4 IgG antibody in subjects who convert to MS
Each subject shall be followed up for 2 years after enrolment. At baseline, routine examinations shall be performed to confirm subject's neurological episode. After the baseline visit, the subject shall be instructed to return for further examination if he/she experiences a relapse. During the follow-up examinations, the treating physician shall determine whether the subject fulfil the diagnostic criteria for MS.
If subject is being diagnosed with MS, he/she shall be considered as reaching the end of his/her study participation. Further management of the MS condition will be at the discretion of the treating physician. During 2-year follow-up period, telephone calls to the subject shall be made quarterly to assess subject's neurological and/or visual status and to remind subject that he/she need to return for evaluation in the event of a relapse. All data will be collected using a standardised case report form (CRF).
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Clinical isolated syndrome, Demyelination
- Medical subject headings
- Multiple Sclerosis, Demyelinating Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who convert to multiple sclerosis (MS), defined by McDonald criteria (Version 2005), over 2 years from the first episode of Clinically Isolated Syndrome (CIS)
At each and every visit, routine neurological and or ophthalmologic examinations will be performed to determine whether subject has progress to MS.
Measured: Baseline to 2 years
Secondary outcomes (4)
Duration between first episode of neurological event and diagnosis of MS
Measured: Baseline to 2 years
Proportion of subjects with conventional MS and optic-spinal MS (OSMS)
Measured: Baseline to 2 years
Proportion of subjects with anti-AQP4 IgG antibody
Blood samples shall be taken at baseline, 12-16 weeks after baseline and end of study (for subjects who converted to MS) for anti-AQP4 IgG antibody measurements
Measured: Baseline to 2 years
Association between baseline demographics/disease characteristics and progression to MS
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startNov 2008
- Primary completionOct 2014
- Study completionOct 2014
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
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ching-Piao Tsai, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112657
- Sponsor's protocol ID
- EMR200077-504
- Acronym
- NEO
- Status last verified
- Nov 2014
- First submitted
- 10 Mar 2010
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study On The Progression Of Clinically Isolated Syndrome (CIS) To Multiple Sclerosis Over A 2-year Period
- ClinicalTrials.gov ID
- NCT01112657
- Acronym / sponsor ID
- NEO / EMR200077-504
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Clinical isolated syndrome, Demyelination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Apr 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 a prospective, multicentric, observational study with a 2 years recruitment period. The purpose of the study is to observe the multiple sclerosis (MS) progression of subjects since their first episode of neurological event and secondly, to determine status of anti-AQP4 immunoglobulin (IgG) antibody in MS subjects.
Detailed description
Multiple sclerosis is chronic, inflammatory disease of the central nervous system (CNS) characterised by areas of demyelination, or plaques, in the CNS. In 85% of subjects who later develop MS, clinical onset is with an acute or subacute episode of neurological disturbance due to a single white-matter lesion (e.g. optic neuritis, or an isolated brainstem or partial spinal-cord syndrome). This presentation is known as a Clinically Isolated Syndrome (CIS). Because a CIS is typically the earliest clinical expression of MS, research on subjects with a CIS may provide new insights into early pathological changes and pathogenetic mechanisms that might affect the course of the disorder.
In the group of subjects with optic-spinal MS (OSMS), the main lesions are typically confined to the optic nerve and spinal cord. In Asians, OSMS has similar features to the relapsing remitting form of neuromyelitis optica (NMO) seen in Westerners. It is still a matter of debate whether NMO represents a disease entity in itself or whether it is a subform of MS. Early differentiation of NMO from MS is highly desirable, as treatment options and prognoses differ widely. Recently, a new serum autoantibody (NMO-IgG) has been detected in NMO subjects. The binding sites of this autoantibody were reported to colocalize with aquaporin 4 (AQP4) water channels. Optic-spinal MS is sometime suggested to be NMO based on the frequent detection of the anti-AQP4 IgG antibody. In Taiwan, study has shown that 56% of MS subjects were of the optic-spinal type.
OBJECTIVES
The study is designed firstly, to observe the MS progression of subjects since their first episode of neurological event and secondly, to determine status of anti-AQP4 IgG antibody in MS subjects.
Primary objective:
- To describe the progression of subjects who have experienced a CIS to MS over a 2-year period
Secondary objectives:
- To assess the relationship between CIS and MS including optic-spinal MS (OSMS)
- To determine the status of anti-AQP4 IgG antibody in subjects who convert to MS
Each subject shall be followed up for 2 years after enrolment. At baseline, routine examinations shall be performed to confirm subject's neurological episode. After the baseline visit, the subject shall be instructed to return for further examination if he/she experiences a relapse. During the follow-up examinations, the treating physician shall determine whether the subject fulfil the diagnostic criteria for MS.
If subject is being diagnosed with MS, he/she shall be considered as reaching the end of his/her study participation. Further management of the MS condition will be at the discretion of the treating physician. During 2-year follow-up period, telephone calls to the subject shall be made quarterly to assess subject's neurological and/or visual status and to remind subject that he/she need to return for evaluation in the event of a relapse. All data will be collected using a standardised case report form (CRF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects who have experienced a single, first clinical event potentially suggestive of MS within the last 2 years from study entry.
Key inclusion criteria (3 listed)
- Subjects aged between 6-60 years, both inclusive
- Subjects who have experienced a single, first clinical event potentially suggestive of MS within the last 2 years from study entry. The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic, other than paresthesia or vegetative dysfunction
- Subjects who have given written informed consent.
Key exclusion criteria (4 listed)
- Subjects with the diagnosis of MS
- Subjects with other disease that could better explain the subject's signs and symptoms
- Subjects who are scheduled to participate in any interventional treatment trial
- Subjects who have any condition that could interfere with MRI evaluation
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
Proportion of subjects who convert to multiple sclerosis (MS), defined by McDonald criteria (Version 2005), over 2 years from the first episode of Clinically Isolated Syndrome (CIS)
Time frame: Baseline to 2 years
At each and every visit, routine neurological and or ophthalmologic examinations will be performed to determine whether subject has progress to MS.
4 secondary outcomes
Duration between first episode of neurological event and diagnosis of MS
Time frame: Baseline to 2 years
Proportion of subjects with conventional MS and optic-spinal MS (OSMS)
Time frame: Baseline to 2 years
Proportion of subjects with anti-AQP4 IgG antibody
Time frame: Baseline to 2 years
Association between baseline demographics/disease characteristics and progression to MS
Time frame: Baseline to 2 years
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 13 Nov 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.
Ching-Piao Tsai, MD principal investigator
Taipei Veterans General Hospital, Taiwan
6 sites 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 6 sites 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 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Proportion of subjects who convert to multiple sclerosis (MS), defined by McDonald criteria (Version 2005), over 2 years from the first episode of Clinically Isolated Syndrome (CIS) (time frame: Baseline to 2 years). 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 13 Nov 2014.