Multiple Sclerosis, Relapsing RemittingNCT01080040
To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, Relapsing Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.
Trial summary
This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL). Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing Remitting
- How many people
- 150 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2008to Mar 2013
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects with established diagnosis of RRSM for more than one year.
Who may be able to join
- Subjects aged from 21 60 years of age
- Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
- Subjects with a diagnosis of RRMS for more than one year
- The subject who have signed the Informed Consent
Who cannot join
- Subjects with other causes of spasticity
- Subjects with other clinical forms of MS (different from relapsing-remitting)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina
This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).
The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.
Read the detailed description
One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.
The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.
The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Keywords
- Multiple Sclerosis, Relapsing Remitting, Quality of life
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the prevalence of spasticity in subjects with RRMS
Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36
Measured: Initial visit (Day 0) to 24 months
Secondary outcomes (2)
Evaluation of the impact of spasticity on the quality of life of subjects with RRMS
Measured: Initial visit (Day 0) to 24 months
Evaluation of the changes in spasticity after 24 months
Measured: Initial visit (Day 0) to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionMar 2013
- Study completionMar 2013
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.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Jose A. Brizuela, Principal investigator, Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080040
- Sponsor's protocol ID
- EMR200077-507
- Status last verified
- Oct 2013
- First submitted
- 2 Mar 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina
- ClinicalTrials.gov ID
- NCT01080040
- Acronym / sponsor ID
- EMR200077-507
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Keywords
- Multiple Sclerosis, Relapsing Remitting, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 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 study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).
The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.
Detailed description
One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.
The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.
The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects with established diagnosis of RRSM for more than one year.
Key inclusion criteria (4 listed)
- Subjects aged from 21 60 years of age
- Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
- Subjects with a diagnosis of RRMS for more than one year
- The subject who have signed the Informed Consent
Key exclusion criteria (2 listed)
- Subjects with other causes of spasticity
- Subjects with other clinical forms of MS (different from relapsing-remitting)
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
Assess the prevalence of spasticity in subjects with RRMS
Time frame: Initial visit (Day 0) to 24 months
Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36
2 secondary outcomes
Evaluation of the impact of spasticity on the quality of life of subjects with RRMS
Time frame: Initial visit (Day 0) to 24 months
Evaluation of the changes in spasticity after 24 months
Time frame: Initial visit (Day 0) to 24 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 16 Oct 2013.
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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.
Dr. Jose A. Brizuela principal investigator
Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.
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, Relapsing Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.
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 2 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 16 Oct 2013. 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 Argentina. 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?
Assess the prevalence of spasticity in subjects with RRMS (time frame: Initial visit (Day 0) to 24 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 16 Oct 2013.