Resistance Training and Amino Pyridine in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143167
• Other study ID #: RETRAP
• Secondary ID: 2011-002959-34
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: August 2018
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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, = ?-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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• SR-fampridine
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.
• Placebo

Locations

Country	Name	City	State
Denmark	Sydvestjysk Sygehus	Esbjerg
Denmark	Odense University Hospital	Odense
Denmark	Sygehus Sønderjylland	Sønderborg
Denmark	Sygehus Lillebælt	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Biogen, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle power in the lower limbs	Muscle power in the lower limbs is measured by dynamometry pre and post resistance training	Muscle power will be measured after 14 weeks of resistance training.
Secondary	Activity	Activity measured by accelerometry.	Accelerometry is measured after 14 weeks of resistance training
Secondary	Walking capacity	Walking capacity measured by the Six Spot Step Test (SSST)	Walking capacity is measured after 26 weeks of resistance training
Secondary	Walking speed	Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT)	Walking speed is measured after 26 weeks of resistance training
Secondary	Functional capacity in the lower limbs	Functional capacity measured by the Chair Stand Test (CST)	Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training
Secondary	Self rated walking capacity	Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12)	Self rated walking capacity is measured after 26 weeks of resistance training