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Resistance Training and Amino Pyridine in Multiple Sclerosis (RETRAP)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
SR-fampridine
Placebo
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sydvestjysk Sygehus
  • Odense University Hospital
  • Sygehus Sønderjylland
  • Sygehus Lillebælt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SR-fampridine/placebo

Placebo/SR-fampridine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Muscle power in the lower limbs
Muscle power in the lower limbs is measured by dynamometry pre and post resistance training

Secondary Outcome Measures

Activity
Activity measured by accelerometry.
Walking capacity
Walking capacity measured by the Six Spot Step Test (SSST)
Walking speed
Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT)
Functional capacity in the lower limbs
Functional capacity measured by the Chair Stand Test (CST)
Self rated walking capacity
Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12)

Full Information

First Posted
May 9, 2014
Last Updated
August 22, 2018
Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark, Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02143167
Brief Title
Resistance Training and Amino Pyridine in Multiple Sclerosis
Acronym
RETRAP
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark, Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SR-fampridine/placebo
Arm Type
Experimental
Arm Description
24 weeks of SR-fampridine followed by four weeks of inactive placebo.
Arm Title
Placebo/SR-fampridine
Arm Type
Experimental
Arm Description
24 weeks of inactive placebo followed by four weeks of SR-fampridine
Intervention Type
Drug
Intervention Name(s)
SR-fampridine
Other Intervention Name(s)
Fampyra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Muscle power in the lower limbs
Description
Muscle power in the lower limbs is measured by dynamometry pre and post resistance training
Time Frame
Muscle power will be measured after 14 weeks of resistance training.
Secondary Outcome Measure Information:
Title
Activity
Description
Activity measured by accelerometry.
Time Frame
Accelerometry is measured after 14 weeks of resistance training
Title
Walking capacity
Description
Walking capacity measured by the Six Spot Step Test (SSST)
Time Frame
Walking capacity is measured after 26 weeks of resistance training
Title
Walking speed
Description
Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT)
Time Frame
Walking speed is measured after 26 weeks of resistance training
Title
Functional capacity in the lower limbs
Description
Functional capacity measured by the Chair Stand Test (CST)
Time Frame
Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training
Title
Self rated walking capacity
Description
Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12)
Time Frame
Self rated walking capacity is measured after 26 weeks of resistance training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik B Jensen, MD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydvestjysk Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sygehus Sønderjylland
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Sygehus Lillebælt
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19884575
Citation
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.
Results Reference
background
PubMed Identifier
20976768
Citation
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.
Results Reference
background
PubMed Identifier
19249634
Citation
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.
Results Reference
background

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Resistance Training and Amino Pyridine in Multiple Sclerosis

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