Multiple Sclerosis
Conditions
Brief summary
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
See above
Interventions
DRUGSR-fampridine
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.
DRUGPlacebo
Sponsors
Region of Southern Denmark
Biogen
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle power in the lower limbs | Muscle power will be measured after 14 weeks of resistance training. | Muscle power in the lower limbs is measured by dynamometry pre and post resistance training |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity | Accelerometry is measured after 14 weeks of resistance training | Activity measured by accelerometry. |
| Walking capacity | Walking capacity is measured after 26 weeks of resistance training | Walking capacity measured by the Six Spot Step Test (SSST) |
| Walking speed | Walking speed is measured after 26 weeks of resistance training | Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT) |
| Functional capacity in the lower limbs | Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training | Functional capacity measured by the Chair Stand Test (CST) |
| Self rated walking capacity | Self rated walking capacity is measured after 26 weeks of resistance training | Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) |
Countries
Denmark
Outcome results
None listed