Resistance Training and Amino Pyridine in Multiple Sclerosis
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 50
Inclusion 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
- ...
- 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
- 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 complete T25FW and SSST
Exclusion Criteria
- ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
- Allergy to substances contained in prolonged release Fampridine tablets
- Blood pressure ≥ 160/100
- ...
- ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
- Allergy to substances contained in prolonged release Fampridine tablets
- Blood pressure ≥ 160/100
- Concomitant treatment with carvedilol, propranolol or metformin.
- History of epileptic seizures
- Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
- GFR < 80 ml/min.
- Cancer within five years
- History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
- Breastfeeding
- MS relapse or change in disease modifying treatment (DMT) within 60 days
- 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
- 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
- ...
- 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
- 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 complete T25FW and SSST
Exclusion Criteria
- ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
- Allergy to substances contained in prolonged release Fampridine tablets
- Blood pressure ≥ 160/100
- ...
- ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l
- Allergy to substances contained in prolonged release Fampridine tablets
- Blood pressure ≥ 160/100
- Concomitant treatment with carvedilol, propranolol or metformin.
- History of epileptic seizures
- Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
- GFR < 80 ml/min.
- Cancer within five years
- History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
- Breastfeeding
- MS relapse or change in disease modifying treatment (DMT) within 60 days
- 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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