RETRAP - A study of the effect of combination of resistance training and prolonged-release fampridine on muscle strength in the legs, walking capacity and quality of life in multiple sclerosis patients.

RETRAP - A double blind, randomized, placebo controlled study of the effect of the combination of resistance training and prolonged release fampridine on muscle strength in the lower extremities, walking capacity and quality of life in relapsing remitting multiple sclerosis - RETRAP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002959-34-DK

Enrollment

125

Registered

2013-03-01

Start date

2013-03-11

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis MedDRA version: 15.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 100000004852

Interventions

Trade Name: Fampyra Product Name: Fampyra Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: FAMPRIDINE CAS Number: 504-24-5 Pharmaceutical form of the placebo: Tablet Route of adminis

Eligibility

Sex/Gender

All

Inclusion 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 [34] -age 18-60 years -EDSS 3-6.5 -Pyramidal FS = 2 -Participants must be able to transport self to gym and to the University of Southern Denmark -Participants must be able to complete Timed 25 Foot Walk (T25FW) and Six Spot Step Test (SSST) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 - ALAT = 90 U/l, BASP = 210 U/l, ?-GT = 230 U/l -GFR < 80 ml/min. -History of severe pulmonary disease or unexplained abnormal pulmonary auscultation -Pregnancy -Concomitant treatment with carvedilol, propranolol or metformine.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to examine whether prolonged release fampridine Fampyra can enhance the beneficial effect of physical exercise in patients with MS and to examine whether the combined beneficial effect can increase activity and thereby possibly social participation and Quality of Life in an ICF context (the International Classification of Functioning, Disability and Health) [33]. Furthermore it is the aim to examine whether the potential beneficial effect persists three months after ended intervention and to estimate the influence of both the neural and the muscular component. In addition we will propose evidence-based guidelines for the selection of patients in whom treatment with prolonged release fampridine will be beneficial. ;Secondary Objective: Not applicable;Primary end point(s): 1: Improved muscular strength in the lower extremities measured by dynamometry. 2: Primary endpoint: Self evaluated walking capacity measured by MSWS-12. 3: Walking capacity measured by SSST.;Timepoint(s) of evaluation of this end point: 1: 20 weeks 2: 32 weeks 2: 34 weeks	—

Measure

Time frame

Main Objective: The aim of this study is to examine whether prolonged release fampridine Fampyra can enhance the beneficial effect of physical exercise in patients with MS and to examine whether the combined beneficial effect can increase activity and thereby possibly social participation and Quality of Life in an ICF context (the International Classification of Functioning, Disability and Health) [33]. Furthermore it is the aim to examine whether the potential beneficial effect persists three months after ended intervention and to estimate the influence of both the neural and the muscular component. In addition we will propose evidence-based guidelines for the selection of patients in whom treatment with prolonged release fampridine will be beneficial. ;Secondary Objective: Not applicable;Primary end point(s): 1: Improved muscular strength in the lower extremities measured by dynamometry. 2: Primary endpoint: Self evaluated walking capacity measured by MSWS-12. 3: Walking capacity measured by SSST.;Timepoint(s) of evaluation of this end point: 1: 20 weeks 2: 32 weeks 2: 34 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 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. 2: : Quality of Life measured by SF-36, depression measured by MDI and fatigue measured by FSMC. 3: 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. ;Timepoint(s) of evaluation of this end point: 1: 20 weeks. 2: 32 weeks. 3: 34 weeks.	—

Measure

Time frame

Secondary end point(s): 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. 2: : Quality of Life measured by SF-36, depression measured by MDI and fatigue measured by FSMC. 3: 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. ;Timepoint(s) of evaluation of this end point: 1: 20 weeks. 2: 32 weeks. 3: 34 weeks.

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Countries

Denmark

Contacts

Public ContactSydjysk Skleroseklinik

Department of Neurology, Sønderjylland Hospital

egon.stenager@shs.regionsyddanmark.dk004574182552

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026