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Resistance Training and Amino Pyridine in Multiple Sclerosis

NCT02143167 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-08-23

No results posted yet for this study

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

Interventions

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.

DRUG

Placebo

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • Biogen

    collaborator INDUSTRY

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Henrik B Jensen, MD · University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143167 on ClinicalTrials.gov