RETRAP
What it found
We found no results in the registry or in papers.
This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
Placebo or sham
- Placebo
What it measured
Main measures
Muscle power in the lower limbs
Muscle power will be measured after 14 weeks of resistance training.
Physical function1: Improved muscular strength in the lower extremities measured by dynamometry.
Physical function
Other measures (6)
Activity
Accelerometry is measured after 14 weeks of resistance training
Walking capacity
Walking capacity is measured after 26 weeks of resistance training
Walking and mobilityWalking speed
Walking speed is measured after 26 weeks of resistance training
Disability progressionWalking and mobilityFunctional capacity in the lower limbs
Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training
Self rated walking capacity
Self rated walking capacity is measured after 26 weeks of resistance training
Walking and mobility1: Activity measured by accelerometer, walking capacity measured by SSST, walking speed measured by T25FW and 6MWT, functional capacity in the lower extremities measured by CST and self evaluated walking capacity measured by MSWS-12.
Disability progressionWalking and mobility
Who could take part
Relapsing and progressive · 18 to 60
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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.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.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.
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History
Started
May 2014
Main results due
Jan 2015
Finished
Jan 2015
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