Resistance Training and Amino Pyridine in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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See above

Official Title
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RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: SR-fampridine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria Expandend Disability Status Scale (EDSS) 3-6.5 Pyramidal Functional Score ≥ 2 Participants must be able to transport self to gym and to the University of Southern Denmark Participants must be able to complete T25FW and SSST Fertile female participants are obliged to use hormonal contraceptive measures Exclusion Criteria: History of epileptic seizures MS relapse or change in disease modifying treatment (DMT) within 60 days Cancer within five years Blood pressure ≥ 160/100 Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l GFR < 80 ml/min. History of severe pulmonary disease or unexplained abnormal pulmonary auscultation Pregnancy Breastfeeding Allergy to substances contained in prolonged release Fampridine tablets Concomitant treatment with carvedilol, propranolol or metformin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SR-fampridine/placebo<br>24 weeks of SR-fampridine followed by four weeks of inactive placebo. | Drug: SR-fampridine<br>* 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.<br>* Other names: Fampyra;Drug: Placebo<br> <br> |
| Experimental: Placebo/SR-fampridine<br>24 weeks of inactive placebo followed by four weeks of SR-fampridine | Drug: SR-fampridine<br>* 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.<br>* Other names: Fampyra;Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |