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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002959-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
| Biogen | INDUSTRY |
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Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately 40% of MS patients suffering from this by overcoming partly or total conduction block due to demyelination.
Resistance training has been shown to provide the same kind of benefits for patients by targeting the muscular component of the motor unit. Thus by combining the two it is likely to see an synergistic effect.
This trial is designed as a double blind, randomized placebo controlled trial with subsequent cross-over.
Participants in the two arms will go through the same progressive training program targets at the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives placebo. in the the end there is another four weeks of training after cross-over has been performed.
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR-fampridine/placebo | Experimental | 24 weeks of SR-fampridine followed by four weeks of inactive placebo. |
|
| Placebo/SR-fampridine | Experimental | 24 weeks of inactive placebo followed by four weeks of SR-fampridine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR-fampridine | Drug | One arm receives SR-fampridine 10 mg BID for 24 weeks followed by four weeks of inactive placebo BID. The other arm receives placebo BID for 24 weeks followed by four weeks of SR-fampridine 10 mg BID for four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle power in the lower limbs | Muscle power in the lower limbs is measured by dynamometry pre and post resistance training | Muscle power will be measured after 14 weeks of resistance training. |
| Measure | Description | Time Frame |
|---|---|---|
| Activity | Activity measured by accelerometry. | Accelerometry is measured after 14 weeks of resistance training |
| Walking capacity | Walking capacity measured by the Six Spot Step Test (SSST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik B Jensen, MD | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydvestjysk Sygehus | Esbjerg | 6700 | Denmark | |||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19884575 | Background | Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4. | |
| 20976768 | Background | Goodman 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Placebo | Drug |
|
| Walking capacity is measured after 26 weeks of resistance training |
| Walking speed | Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT) | Walking speed is measured after 26 weeks of resistance training |
| Functional capacity in the lower limbs | Functional capacity measured by the Chair Stand Test (CST) | Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training |
| Self rated walking capacity | Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) | Self rated walking capacity is measured after 26 weeks of resistance training |
| Odense |
| 5000 |
| Denmark |
| Sygehus Sønderjylland | Sønderborg | 6400 | Denmark |
| Sygehus Lillebælt | Vejle | 7100 | Denmark |
| 19249634 | Background | Goodman 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |