Resistance Training and Amino Pyridine in Multiple Sclerosis (RETRAP)

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: SR-fampridine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02143167

RETRAP

2011-002959-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

See above

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

SR-fampridine/placebo

Experimental group

Description:

24 weeks of SR-fampridine followed by four weeks of inactive placebo.

Treatment:

Drug: Placebo

Drug: SR-fampridine

Placebo/SR-fampridine

Experimental group

Description:

24 weeks of inactive placebo followed by four weeks of SR-fampridine

Treatment:

Drug: Placebo

Drug: SR-fampridine