Resistance Training and Amino Pyridine in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02143167
• Date of registration: 09/05/2014
• Prospective Registration: No
• Primary sponsor: University of Southern Denmark
• Public title: Resistance Training and Amino Pyridine in Multiple Sclerosis RETRAP
• Scientific title: RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis
• Date of first enrolment: May 2014
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02143167
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Henrik B Jensen, MD
• Affiliation: University of Southern Denmark

Key inclusion & exclusion criteria

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, = ?-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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: SR-fampridine

Drug: Placebo

Primary Outcome(s)

Muscle power in the lower limbs [Time Frame: Muscle power will be measured after 14 weeks of resistance training.]

Secondary Outcome(s)

Walking capacity [Time Frame: Walking capacity is measured after 26 weeks of resistance training]

Activity [Time Frame: Accelerometry is measured after 14 weeks of resistance training]

Walking speed [Time Frame: Walking speed is measured after 26 weeks of resistance training]

Functional capacity in the lower limbs [Time Frame: Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training]

Self rated walking capacity [Time Frame: Self rated walking capacity is measured after 26 weeks of resistance training]

Secondary ID(s)

RETRAP

2011-002959-34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen

Region of Southern Denmark