Resistance Training and Amino Pyridine in Multiple Sclerosis

NCT02143167 | Completed Phase 4

• 2 other identifiers: RETRAP2011-002959-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Activity

  Accelerometry is measured after 14 weeks of resistance training

• Walking capacity

  Walking capacity is measured after 26 weeks of resistance training

• Walking speed

  Walking speed is measured after 26 weeks of resistance training

• Functional capacity in the lower limbs

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

• Self rated walking capacity

  Self rated walking capacity is measured after 26 weeks of resistance training

Study Arms (2)

SR-fampridine/placebo

EXPERIMENTAL

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

Drug: SR-fampridine; Drug: Placebo

Placebo/SR-fampridine

EXPERIMENTAL

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

Drug: SR-fampridine; Drug: Placebo

Interventions

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.

Also known as: Fampyra

Placebo/SR-fampridine; SR-fampridine/placebo

Placebo DRUG

Placebo/SR-fampridine; SR-fampridine/placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator
• Biogen: collaborator

Study Sites (4)

Sydvestjysk Sygehus

Esbjerg, 6700, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Sygehus Sønderjylland

Sønderborg, 6400, Denmark

Location

Sygehus Lillebælt

Vejle, 7100, Denmark

Location

Related 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.

  PMID: 19884575 BACKGROUND

• 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.

  PMID: 20976768 BACKGROUND

• 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.

  PMID: 19249634 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Henrik B Jensen, MD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

DK (4)