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NCT Number: NCT02143167

Resistance Training and Amino Pyridine in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sydvestjysk Sygehus, Esbjerg, Denmark

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About this study

See above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SR-fampridine

Drug

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.

Other names: Fampyra

Placebo

Drug

Primary outcomes

  1. Muscle power in the lower limbs

    Time frame: 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 outcomes

  1. Activity

    Time frame: Accelerometry is measured after 14 weeks of resistance training

    Activity measured by accelerometry.

  2. Walking capacity

    Time frame: Walking capacity is measured after 26 weeks of resistance training

    Walking capacity measured by the Six Spot Step Test (SSST)

  3. Walking speed

    Time frame: 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)

  4. Functional capacity in the lower limbs

    Time frame: Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training

    Functional capacity measured by the Chair Stand Test (CST)

  5. Self rated walking capacity

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Biogen
  • Region of Southern Denmark

Registry information

Official study 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

Acronym: RETRAP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 20, 2014
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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