RETRAP - A double blind, randomized, placebo controlled study of the effect of the combination of resistance training and prolonged release fampridine on muscle strength in the lower extremities, walking capacity and quality of life in relapsing remitting multiple sclerosis - RETRAP

Sønderjylland Hospital, department of neurology0 个研究点目标入组 125 人开始时间: 2013年3月1日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•-Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria [34]
•-age 18-60 years
•-EDSS 3-6.5
•-Pyramidal FS = 2
•-Participants must be able to transport self to gym and to the University of Southern Denmark
•-Participants must be able to complete Timed 25 Foot Walk (T25FW) and Six Spot Step Test (SSST)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 125
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-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
•- ALAT = 90 U/l, BASP = 210 U/l, ?-GT = 230 U/l
•-GFR < 80 ml/min.
•-History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
•-Pregnancy
•-Concomitant treatment with carvedilol, propranolol or metformine.

发起方

Sønderjylland Hospital, department of neurology