Clinical trial NCT02143167: Resistance Training and Amino Pyridine in Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Biogen
First posted: 2014-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle power in the lower limbs
timeFrame: Muscle power will be measured after 14 weeks of resistance training.
Secondary outcomes:
measure: Activity
timeFrame: Accelerometry is measured after 14 weeks of resistance training
measure: Walking capacity
timeFrame: Walking capacity is measured after 26 weeks of resistance training
measure: Walking speed
timeFrame: Walking speed is measured after 26 weeks of resistance training
measure: Functional capacity in the lower limbs
timeFrame: Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training
measure: Self rated walking capacity
timeFrame: Self rated walking capacity is measured after 26 weeks of resistance training
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Odense
country: Denmark
facility: Odense University Hospital
city: Sønderborg
country: Denmark
facility: Sygehus Sønderjylland
city: Vejle
country: Denmark
facility: Sygehus Lillebælt
Study officials:
affiliation: University of Southern Denmark
name: Henrik B Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.