Recruitment

Recruitment Status
Completed
Estimated Enrollment
50

Inclusion Criteria

Fertile female participants are obliged to use hormonal contraceptive measures
Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria
Participants must be able to transport self to gym and to the University of Southern Denmark
...
Fertile female participants are obliged to use hormonal contraceptive measures
Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria
Participants must be able to transport self to gym and to the University of Southern Denmark
Pyramidal Functional Score ≥ 2
Participants must be able to complete T25FW and SSST
Expandend Disability Status Scale (EDSS) 3-6.5

Exclusion Criteria

Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
History of epileptic seizures
...
Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
History of epileptic seizures
MS relapse or change in disease modifying treatment (DMT) within 60 days
Blood pressure ≥ 160/100
Allergy to substances contained in prolonged release Fampridine tablets
Concomitant treatment with carvedilol, propranolol or metformin.
Breastfeeding
GFR < 80 ml/min.
Cancer within five years
≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
Pregnancy

Summary

Conditions
Multiple Sclerosis
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

See above

See above

Inclusion Criteria

Fertile female participants are obliged to use hormonal contraceptive measures
Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria
Participants must be able to transport self to gym and to the University of Southern Denmark
...
Fertile female participants are obliged to use hormonal contraceptive measures
Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria
Participants must be able to transport self to gym and to the University of Southern Denmark
Pyramidal Functional Score ≥ 2
Participants must be able to complete T25FW and SSST
Expandend Disability Status Scale (EDSS) 3-6.5

Exclusion Criteria

Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
History of epileptic seizures
...
Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
History of epileptic seizures
MS relapse or change in disease modifying treatment (DMT) within 60 days
Blood pressure ≥ 160/100
Allergy to substances contained in prolonged release Fampridine tablets
Concomitant treatment with carvedilol, propranolol or metformin.
Breastfeeding
GFR < 80 ml/min.
Cancer within five years
≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
Pregnancy

Tracking Information

NCT #
NCT02143167
Collaborators
  • Region of Southern Denmark
  • Biogen
Investigators
  • Principal Investigator: Henrik B Jensen, MD University of Southern Denmark
  • Henrik B Jensen, MD University of Southern Denmark
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