Multiple SclerosisMUSTNCT03847545
Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking Technique
A study testing Fampridine in people with Multiple Sclerosis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fampridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Dec 2018to 15 Oct 2021
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fills the criteria for fampridine treatment
- Fills the diagnostic McDonald criteria for MS
- Age between 18 and 100 years
- EDSS between 4 and 7
Who cannot join
- Diagnosed epilepsy
- MS attack or an acute decrease of functional capacity within the last 60 days
- Change in immunomodulatory treatment within the last 60 days
- Cancer within the last 5 years
- Clinically significant systemic disease
- Concurrent treatment with cimetidine, carvediol, propanolol and metformine
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark - Odense Univarsity Hospital
Odense C, 5000
About this study
Official title: Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking
The primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. not receiving fampridine, as well as to relate these results to performance-based measures and biomarkers to explore disease progression and muscle activity, has been cancelled. Instead four exploratory studies that originate from the initial trial registration but with revised aims, outcome measures and time points, have been prepared - see the DEVIATIONS TO TRIAL PROTOCOL included in the Statistical Analysis Plan filed under "Document section".
Summary of original trial registration:
Read more
Despite effective treatments, the majority of patients with multiple sclerosis experience walking impairments to a degree where walking aids or a wheelchair is required. Since 2009, medical treatment of walking impairments has been possible with fampridine, which has proven effective in approximately 40% of the patients. At present, the treatment is offered on the basis of a measurable improved walking function evaluated by simple performance-based walking tests. The treatment is offered on the basis of a measurable improved walking distance.
This is shown today using simple performance-based walking tests that are difficult to complete for those MS patients who are without gait function but could still benefit from fampridine treatment.
Ultrasound speckle tracking is a non-invasive ultrasound technique, with the potential to measure muscle function, including muscle contractility (through strain). Ultrasound speckle tracking is designed for dynamic cardiac muscular examination, but can in a modified version be used for assessment of the skeletal muscles.
The purpose of this project is to use ultrasound speckle tracking to monitor muscle contractility in MS patients receiving vs. not receiving fampridine treatment. Furthermore, to relate these results to biomarkers in blood and urine to examine disease progression and muscle activity.
Read the detailed description
The primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. not receiving fampridine, as well as to relate these results to performance-based measures and biomarkers to explore disease progression and muscle activity, has been cancelled. Instead four exploratory studies that originate from the initial trial registration but with revised aims, outcome measures and time points, have been prepared - see the DEVIATIONS TO TRIAL PROTOCOL included in the Statistical Analysis Plan filed under "Document section"
The detailed description that was included in the original trial registration:
Despite effective treatments, the majority of multiple sclerosis (MS) patients experience difficulty in walking and the need of a walker or wheelchair. Since 2009, medical treatment of walking impairments has been possible with fampridine, which has proven effective at approximately 40% of patients.
At present, the treatment is offered on the basis of a measurable improved walking function evaluated by simple performance-based walking tests. Multiple sclerosis patients, who do not have the sufficient gait function to complete these tests, may still benefit from fampridine treatment in other activities of daily life. However, these patients are currently not eligible for fampridine treatment due to current requirements of a measurable improved effect.
Ultrasound speckle tracking (UST) is a non-invasive ultrasound technique, with the potential to directly analyze the muscle strain in the muscles. UST is designed for dynamic cardiac muscular examination, but can be used in a modified version for skeletal muscle examination. The technique has already been tested in a minor pilot study with MS patients.
The objective of the present study is to use UST to monitor muscle strain in the weight-bearing and transfer-related muscles in MS patients who receive fampridine vs. patients who do not receive this treatment. Strain is evaluated over time during different isometric contractions. Furthermore, the relation between these results and the performance based measures of clinical function and biomarkers in blood and urine will be examined to explore disease progression and muscle activity.
MS patients will be recruited from sclerosis clinics at Odense University Hospital (OUH), Esbjerg, Kolding and Sønderborg. All participants will undergo the existing standard practice for patients receiving fampridine treatment, including functional and neurological examination. In addition to the regular practice, participants will be offered UST, answer relevant questionnaires as well as the collection of blood- and urine samples (8 ml of blood and 10 ml of urine will be centrifuged and kept in 0.5 ml aliquots and stored in the already established biobank at the Department of Neurology, OUH.
Participants will be tested at baseline (just before start of fampridine treatment), after 14 days of treatment and again one year after baseline. All three test sessions will include the above mentioned testing protocol. The primary end-point will be at one-year follow-up.
A sub-group of 30 randomly selected participants will supplementary perform a 3-dimensional gait analysis in the motion laboratory. A list generated from 30 randomly found numbers from 1 to 60 will be used. In the motion laboratory, the outcomes: Kinematics, kinetics, gait summary measures and temporo spatial outcome measures will be generated.
Participants, who respond to the fampridine after 14 days of treatment, will continue in the project as cases, whereas non-responders persist in the trial as an untreated control group.
The study is approved by the Regional Committees on Health Research Ethics for Southern Denmark, project Identification: S-20170203. Sample size is based on previously published studies regarding effect of fampridine treatment as well as already detected differences in pilot data obtained from 2 MS patients and 4 healthy controls on m supraspinatus at 40% of maximal load. With an alpha value of p<0.05 and a power of 0.80, sample size is 60.
The study will be conducted in accordance to the Good Clinical Practice and the Declaration of Helsinki and has been approved by the National Committee on Health Research Ethics and the Danish Data Protection Agency.
To our knowledge, this is the first study to evaluate muscle function in MS patients through muscle strain measured using UST as well as examine its correlation to biomarkers for disease progression and muscle activity. Consequently, the result of the present study could expand clinical guidelines for fampridine treatment in MS patients. Furthermore, UST could be implemented for clinical use in assessing muscle strength and treatment response and can ultimately be used to monitor disease progression in MS patients independent of fampridine treatment. The included analysis of blood and urine opens new opportunities for diagnostic and prognostic biomarkers. In addition to provide new knowledge of disease mechanisms, it may also serve as potential new targets for future treatments.
- Conditions
- Multiple Sclerosis
- Being tested
- Fampridine
- Keywords
- Speckle tracking ultrasonography, Muscle strain, Fampridine, Multiple Sclerosis, Neurological diseases, Biomarkers, muscle contractility
- Medical subject headings
- Multiple Sclerosis, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FampridineDrug
sustained-release tablet 10 mg morning and evening.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participants receive Fampridine treatment (10 mg x 2 daily) for 14 days. They are testet prior to treatment and following the 14 days of treatment. Receives: Drug: Fampridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Profile Score (GPS) - (subgroup of 30 allocated to 3D gait analysis)
Change in GPS. GPS is a summary measure of kinematic data. The GPS evaluates the overall quality of gait by comparing nine kinematic variables, described as Gait Variable Scores (GVS), relative to normative data.
GPS is the root mean square (RMS) difference between the data of relevant kinematic variables of an individual patient and the averaged data from a reference group comprised of people without gait impairments.
Originally we had registred that we would use the Gait Deviation Index (GDI). GDI is a unitless value from 0 to 100. It is based upon kinematic data and is an overall quantitative index that summarises the overall gait pathology into a single score for each patient by comparison with non-pathological gait.
The GDI and GPS is highly correlated. We chose to use the GPS due to the inclusion of the GVS.
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Secondary outcomes (10)
Gait Variable Scores (GVS) - (subgroup of 30 allocated to 3D gait analysis)
Change in GVS. GVS refers to the Root Mean Square difference between the data of the following kinematic variables of an individual patient and the averaged data from a reference group comprised of people without gait impairments:
Pelvic tilt, obliquity and rotation; hip flexion-extension, adduction-abduction, and rotation; knee flexion-extension; ankle dorsiflexion; and foot progression.
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Functional test - 6 Spot Step Test (SSST)
Change in time it takes the participant to walk through a rectangular area of 1x 5 meters while 5 cylinder blocks must be kicked out of 5 circles marked on the floor.
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Functional test - Timed 25 Footwalk (T25-FW)
Change in time it takes the participant to walk as safe and as quickly as possible through a straight clearly marked lane of 7.62 meters (25 feet).
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Functional test - 2-minute Walk Test (2MWT)
Change in distance that the participant is able to walk in 2 minutes.
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking speed - (subgroup of 30 allocated to 3D gait analysis)
Change in walking speed (m/s)
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Step length - (subgroup of 30 allocated to 3D gait analysis)
Change in step length (m)
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Step width - (subgroup of 30 allocated to 3D gait analysis)
Change in step width (m)
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Stride length - (subgroup of 30 allocated to 3D gait analysis)
Change in stride length (m)
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Cadence - (subgroup of 30 allocated to 3D gait analysis)
Change in cadence (steps/min.)
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Questionnaire - 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Danish version
Change in MSWS-12. Data is converted to a scale from 0 to 100, where 0 represents the best and 100 the worst. A change score of at least -4 represents a clinically meaningful improvement in the gait function.
Measured: Baseline, 14 days (Change from baseline to 14 days follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start12 Dec 2018
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort Study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Region of Southern Denmark, The Augustinus Foundation, Denmark., Lounkær Fonden, Fonden for scleroseramte på Fyn, The Danish Multiple Sclerosis Society, TH MAIGAARDS EFTF. FRU LILY BENTHINE LUNDS FOND AF 1. JUNI 1978, Fonden til Lægevidenskabens Fremme, Overlægeråds forskningsfond
- Responsible party
- Sponsor
- Investigators
- Helle H. Nielsen, MD, PhD, Study director, Department of Neurology, Odense University Hospital, Odense, DenmarkMaria Thorning, MSc, Principal investigator, Department of Neurology, Odense University Hospital, Odense, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847545
- Sponsor's protocol ID
- mariathorning
- Acronym
- MUST
- Status last verified
- Mar 2022
- First submitted
- 19 Dec 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available.
Publications
Gottberg K, Einarsson U, Ytterberg C, de Pedro Cuesta J, Fredrikson S, von Koch L, Widen Holmqvist L. Health-related quality of life in a population-based sample of people with multiple sclerosis in Stockholm County. Mult Scler. 2006 Oct;12(5):605-12. doi: 10.1177/1352458505070660.
PubMed 17086907Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
PubMed 20976768Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
PubMed 19249634Solari A, Uitdehaag B, Giuliani G, Pucci E, Taus C. Aminopyridines for symptomatic treatment in multiple sclerosis. Cochrane Database Syst Rev. 2001;2002(4):CD001330. doi: 10.1002/14651858.CD001330.
PubMed 11687106Jensen H, Ravnborg M, Mamoei S, Dalgas U, Stenager E. Changes in cognition, arm function and lower body function after slow-release Fampridine treatment. Mult Scler. 2014 Dec;20(14):1872-80. doi: 10.1177/1352458514533844. Epub 2014 May 22.
PubMed 24852920Jensen HB, Mamoei S, Ravnborg M, Dalgas U, Stenager E. Distribution-based estimates of minimum clinically important difference in cognition, arm function and lower body function after slow release-fampridine treatment of patients with multiple sclerosis. Mult Scler Relat Disord. 2016 May;7:58-60. doi: 10.1016/j.msard.2016.03.007. Epub 2016 Mar 18.
PubMed 27237758Jensen HB, Ravnborg M, Dalgas U, Stenager E. 4-Aminopyridine for symptomatic treatment of multiple sclerosis: a systematic review. Ther Adv Neurol Disord. 2014 Mar;7(2):97-113. doi: 10.1177/1756285613512712.
PubMed 24587826Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zaca V, Ballo P, D'Andrea A, Muraru D, Losi M, Agricola E, D'Errico A, Buralli S, Sciomer S, Nistri S, Badano L; Echocardiography Study Group Of The Italian Society Of Cardiology (Rome, Italy). Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med. 2011 Jan;30(1):71-83. doi: 10.7863/jum.2011.30.1.71.
PubMed 21193707Frich, L.H., et al., Direct isometric muscle strain analyses using speckle tracking technology. A validation study, in European Muscle Conference 2017. 2017, Journal of Muscle Research and Cell Motility: Potsdam
Thorning M, Nielsen HH, Frich LH, Jensen HB, Lambertsen KL, Holsgaard-Larsen A. Gait quality and function after fampridine treatment in patients with multiple sclerosis - A prospective cohort study. Clin Biomech (Bristol). 2022 Dec;100:105826. doi: 10.1016/j.clinbiomech.2022.105826. Epub 2022 Nov 17.
PubMed 36436320
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking
- ClinicalTrials.gov ID
- NCT03847545
- Acronym / sponsor ID
- MUST / mariathorning
- Conditions
- Multiple Sclerosis
- Keywords
- Speckle tracking ultrasonography, Muscle strain, Fampridine, Multiple Sclerosis, Neurological diseases, Biomarkers, muscle contractility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Region of Southern Denmark, The Augustinus Foundation, Denmark., Lounkær Fonden, Fonden for scleroseramte på Fyn, The Danish Multiple Sclerosis Society, TH MAIGAARDS EFTF. FRU LILY BENTHINE LUNDS FOND AF 1. JUNI 1978, Fonden til Lægevidenskabens Fremme, Overlægeråds forskningsfond
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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 primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. not receiving fampridine, as well as to relate these results to performance-based measures and biomarkers to explore disease progression and muscle activity, has been cancelled. Instead four exploratory studies that originate from the initial trial registration but with revised aims, outcome measures and time points, have been prepared - see the DEVIATIONS TO TRIAL PROTOCOL included in the Statistical Analysis Plan filed under "Document section".
Summary of original trial registration:
Despite effective treatments, the majority of patients with multiple sclerosis experience walking impairments to a degree where walking aids or a wheelchair is required. Since 2009, medical treatment of walking impairments has been possible with fampridine, which has proven effective in approximately 40% of the patients. At present, the treatment is offered on the basis of a measurable improved walking function evaluated by simple performance-based walking tests. The treatment is offered on the basis of a measurable improved walking distance.
This is shown today using simple performance-based walking tests that are difficult to complete for those MS patients who are without gait function but could still benefit from fampridine treatment.
Ultrasound speckle tracking is a non-invasive ultrasound technique, with the potential to measure muscle function, including muscle contractility (through strain). Ultrasound speckle tracking is designed for dynamic cardiac muscular examination, but can in a modified version be used for assessment of the skeletal muscles.
The purpose of this project is to use ultrasound speckle tracking to monitor muscle contractility in MS patients receiving vs. not receiving fampridine treatment. Furthermore, to relate these results to biomarkers in blood and urine to examine disease progression and muscle activity.
Detailed description
The primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. not receiving fampridine, as well as to relate these results to performance-based measures and biomarkers to explore disease progression and muscle activity, has been cancelled. Instead four exploratory studies that originate from the initial trial registration but with revised aims, outcome measures and time points, have been prepared - see the DEVIATIONS TO TRIAL PROTOCOL included in the Statistical Analysis Plan filed under "Document section"
The detailed description that was included in the original trial registration:
Despite effective treatments, the majority of multiple sclerosis (MS) patients experience difficulty in walking and the need of a walker or wheelchair. Since 2009, medical treatment of walking impairments has been possible with fampridine, which has proven effective at approximately 40% of patients.
At present, the treatment is offered on the basis of a measurable improved walking function evaluated by simple performance-based walking tests. Multiple sclerosis patients, who do not have the sufficient gait function to complete these tests, may still benefit from fampridine treatment in other activities of daily life. However, these patients are currently not eligible for fampridine treatment due to current requirements of a measurable improved effect.
Ultrasound speckle tracking (UST) is a non-invasive ultrasound technique, with the potential to directly analyze the muscle strain in the muscles. UST is designed for dynamic cardiac muscular examination, but can be used in a modified version for skeletal muscle examination. The technique has already been tested in a minor pilot study with MS patients.
The objective of the present study is to use UST to monitor muscle strain in the weight-bearing and transfer-related muscles in MS patients who receive fampridine vs. patients who do not receive this treatment. Strain is evaluated over time during different isometric contractions. Furthermore, the relation between these results and the performance based measures of clinical function and biomarkers in blood and urine will be examined to explore disease progression and muscle activity.
MS patients will be recruited from sclerosis clinics at Odense University Hospital (OUH), Esbjerg, Kolding and Sønderborg. All participants will undergo the existing standard practice for patients receiving fampridine treatment, including functional and neurological examination. In addition to the regular practice, participants will be offered UST, answer relevant questionnaires as well as the collection of blood- and urine samples (8 ml of blood and 10 ml of urine will be centrifuged and kept in 0.5 ml aliquots and stored in the already established biobank at the Department of Neurology, OUH.
Participants will be tested at baseline (just before start of fampridine treatment), after 14 days of treatment and again one year after baseline. All three test sessions will include the above mentioned testing protocol. The primary end-point will be at one-year follow-up.
A sub-group of 30 randomly selected participants will supplementary perform a 3-dimensional gait analysis in the motion laboratory. A list generated from 30 randomly found numbers from 1 to 60 will be used. In the motion laboratory, the outcomes: Kinematics, kinetics, gait summary measures and temporo spatial outcome measures will be generated.
Participants, who respond to the fampridine after 14 days of treatment, will continue in the project as cases, whereas non-responders persist in the trial as an untreated control group.
The study is approved by the Regional Committees on Health Research Ethics for Southern Denmark, project Identification: S-20170203. Sample size is based on previously published studies regarding effect of fampridine treatment as well as already detected differences in pilot data obtained from 2 MS patients and 4 healthy controls on m supraspinatus at 40% of maximal load. With an alpha value of p<0.05 and a power of 0.80, sample size is 60.
The study will be conducted in accordance to the Good Clinical Practice and the Declaration of Helsinki and has been approved by the National Committee on Health Research Ethics and the Danish Data Protection Agency.
To our knowledge, this is the first study to evaluate muscle function in MS patients through muscle strain measured using UST as well as examine its correlation to biomarkers for disease progression and muscle activity. Consequently, the result of the present study could expand clinical guidelines for fampridine treatment in MS patients. Furthermore, UST could be implemented for clinical use in assessing muscle strength and treatment response and can ultimately be used to monitor disease progression in MS patients independent of fampridine treatment. The included analysis of blood and urine opens new opportunities for diagnostic and prognostic biomarkers. In addition to provide new knowledge of disease mechanisms, it may also serve as potential new targets for future treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort Study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: FampridineThe participants receive Fampridine treatment (10 mg x 2 daily) for 14 days. They are testet prior to treatment and following the 14 days of treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fills the criteria for fampridine treatment
- Fills the diagnostic McDonald criteria for MS
- Age between 18 and 100 years
- EDSS between 4 and 7
Key exclusion criteria (6 listed)
- Diagnosed epilepsy
- MS attack or an acute decrease of functional capacity within the last 60 days
- Change in immunomodulatory treatment within the last 60 days
- Cancer within the last 5 years
- Clinically significant systemic disease
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 |
|---|---|---|
| Fampridinesustained-release tablet 10 mg morning and evening. | Drug | Intervention |
Primary outcome
Gait Profile Score (GPS) - (subgroup of 30 allocated to 3D gait analysis)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Change in GPS. GPS is a summary measure of kinematic data. The GPS evaluates the overall quality of gait by comparing nine kinematic variables, described as Gait Variable Scores (GVS), relative to normative data. GPS is the root mean square (RMS) difference between the data of relevant kinematic variables of an individual patient and the averaged data from a reference group comprised of people without gait impairments. Originally we had registred that we would use the Gait Deviation Index (GDI). GDI is a unitless value from 0 to 100. It is based upon kinematic data and is an overall quantitative index that summarises the overall gait pathology into a single score for each patient by comparison with non-pathological gait. The GDI and GPS is highly correlated. We chose to use the GPS due to the inclusion of the GVS.
10 secondary outcomes
Gait Variable Scores (GVS) - (subgroup of 30 allocated to 3D gait analysis)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Functional test - 6 Spot Step Test (SSST)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Functional test - Timed 25 Footwalk (T25-FW)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Functional test - 2-minute Walk Test (2MWT)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Walking speed - (subgroup of 30 allocated to 3D gait analysis)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Step length - (subgroup of 30 allocated to 3D gait analysis)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Step width - (subgroup of 30 allocated to 3D gait analysis)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Stride length - (subgroup of 30 allocated to 3D gait analysis)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Cadence - (subgroup of 30 allocated to 3D gait analysis)
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
Questionnaire - 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Danish version
Time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)
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 5 Apr 2022.
- Background: PubMed 17086907Gottberg K, Einarsson U, Ytterberg C, de Pedro Cuesta J, Fredrikson S, von Koch L, Widen Holmqvist L. Health-related quality of life in a population-based sample of people with multiple sclerosis in Stockholm County. Mult Scler. 2006 Oct;12(5):605-12. doi: 10.1177/1352458505070660.
- Background: PubMed 20976768Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
- Background: PubMed 19249634Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
- Background: PubMed 11687106Solari A, Uitdehaag B, Giuliani G, Pucci E, Taus C. Aminopyridines for symptomatic treatment in multiple sclerosis. Cochrane Database Syst Rev. 2001;2002(4):CD001330. doi: 10.1002/14651858.CD001330.
- Background: PubMed 24852920Jensen H, Ravnborg M, Mamoei S, Dalgas U, Stenager E. Changes in cognition, arm function and lower body function after slow-release Fampridine treatment. Mult Scler. 2014 Dec;20(14):1872-80. doi: 10.1177/1352458514533844. Epub 2014 May 22.
- Background: PubMed 27237758Jensen HB, Mamoei S, Ravnborg M, Dalgas U, Stenager E. Distribution-based estimates of minimum clinically important difference in cognition, arm function and lower body function after slow release-fampridine treatment of patients with multiple sclerosis. Mult Scler Relat Disord. 2016 May;7:58-60. doi: 10.1016/j.msard.2016.03.007. Epub 2016 Mar 18.
- Background: PubMed 24587826Jensen HB, Ravnborg M, Dalgas U, Stenager E. 4-Aminopyridine for symptomatic treatment of multiple sclerosis: a systematic review. Ther Adv Neurol Disord. 2014 Mar;7(2):97-113. doi: 10.1177/1756285613512712.
- Background: PubMed 21193707Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zaca V, Ballo P, D'Andrea A, Muraru D, Losi M, Agricola E, D'Errico A, Buralli S, Sciomer S, Nistri S, Badano L; Echocardiography Study Group Of The Italian Society Of Cardiology (Rome, Italy). Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med. 2011 Jan;30(1):71-83. doi: 10.7863/jum.2011.30.1.71.
- BackgroundFrich, L.H., et al., Direct isometric muscle strain analyses using speckle tracking technology. A validation study, in European Muscle Conference 2017. 2017, Journal of Muscle Research and Cell Motility: Potsdam
- Derived from this study: PubMed 36436320Thorning M, Nielsen HH, Frich LH, Jensen HB, Lambertsen KL, Holsgaard-Larsen A. Gait quality and function after fampridine treatment in patients with multiple sclerosis - A prospective cohort study. Clin Biomech (Bristol). 2022 Dec;100:105826. doi: 10.1016/j.clinbiomech.2022.105826. Epub 2022 Nov 17.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available.
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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.
Helle H. Nielsen, MD, PhD study director
Department of Neurology, Odense University Hospital, Odense, Denmark
Maria Thorning, MSc principal investigator
Department of Neurology, Odense University Hospital, Odense, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fampridine in people with Multiple Sclerosis, run by University of Southern Denmark at 1 site in Denmark.
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 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 5 Apr 2022. 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 Denmark. 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?
Gait Profile Score (GPS) - (subgroup of 30 allocated to 3D gait analysis) (time frame: Baseline, 14 days (Change from baseline to 14 days follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847545, which also lists 10 linked publications.
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 5 Apr 2022.