CompletedPhase 4Relapsing and progressiveNCT021431672011-002959-34

What it found

No result 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

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 function
  • 1: 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 mobility
  • Walking speed

    Walking speed is measured after 26 weeks of resistance training

    Disability progressionWalking and mobility
  • Functional 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 mobility
  • 1: 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

Loading reviews and guidelines…

Related trials

History

    1. Started

      May 2014

    2. Main results due

      Jan 2015

    3. Finished

      Jan 2015

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error