Resistance Training and Amino Pyridine in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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See above

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SR-fampridine/placebo

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

Group Type EXPERIMENTAL

SR-fampridine

Intervention Type 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.

Placebo

Intervention Type DRUG

Placebo/SR-fampridine

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

Group Type EXPERIMENTAL

SR-fampridine

Intervention Type 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.

Placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Fampyra

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No