The European Study on Enzyme Therapy in Multiple Sclerosis (ESEMS): results of a multicentre, randomized, double-blind, placebo-controlled study

2001 ◽  
pp. 419-425
1996 ◽  
Vol 1 (6) ◽  
pp. 372-375 ◽  
Author(s):  
H Nyland ◽  
K-M Myhr ◽  
F Lillås ◽  
AI Smievoll ◽  
T Riise ◽  
...  

A multicentre, randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of 4.5 and 9.0 MIU recombinant human interferon alfa-2a (Rof eron-A™) given thrice weekly in patients with relapsing-remittent multiple sclerosis is described. The patients are treated for 6 months followed by a 6 months drug-free period. The primary objective is to determine new disease activity analysed by monthly MRI with gadodiamide (GdDTPA-BMA, Omniscan™). The study is conducted at eight centers in Norway and is completed in January 1996.


1996 ◽  
Vol 2 (5) ◽  
pp. 227-232 ◽  
Author(s):  
Jorgen F Nielsen ◽  
Thomas Sinkjaer ◽  
Johannes Jakobsen

The effect of repetitive magnetic stimulation on spasticity was evaluated in 38 patients with multiple sclerosis in a double-blind placebo-controlled study. One group was treated with repetitive magnetic stimulation (n=2l) and the other group with sham stimulation (n=l7). Both groups were seated twice daily for 7 consecutive days. Primary end-points of the study were changes in the patients self-score, in clinical spasticity score, and in the stretch reflex threshold. The self-score of ease of daily day activities improved by 22% (P=0.007) after treatment and by 29% (P=0.004) after sham stimulation. The clinical spasticity score improved 3.3±4.7 arbitrary unit (AU) in treated patients and 0.7±2.5 AU in sham stimulation (P-0.003). The stretch reflex threshold increased 4.3±7.5 degls in treated patients and-3.8±9.7 degls in sham stimulation (P=0.001). The data presented in this study supports the idea that repetitive magnetic stimulation has an antispastic effect in multiple sclerosis. Future studies should darify the optimal treatment regimen.


CNS Drugs ◽  
2018 ◽  
Vol 32 (7) ◽  
pp. 661-672 ◽  
Author(s):  
Ayman Tourbah ◽  
Olivier Gout ◽  
Alain Vighetto ◽  
Véronique Deburghgraeve ◽  
Jean Pelletier ◽  
...  

2007 ◽  
Vol 13 (3) ◽  
pp. 357-368 ◽  
Author(s):  
A.D. Goodman ◽  
J.A. Cohen ◽  
A. Cross ◽  
T. Vollmer ◽  
M. Rizzo ◽  
...  

Objective To determine the safety of sustained-release 4-aminopyridine in subjects with mutiple sclerosis (MS) and to examine dose-related efficacy up to 40 mg twice daily. Method Multicenter, randomized, double-blind, placebo-controlled, study. Following a 4-week baseline peroid, subjects were randomly assigned to receive Fampridine-SR (n=25, doses from 10 to 40 mg twice daily, increasing in 5 mg increments weekly) or placebo (n=11). A battery of assessments was performed weekly, including the MS Functional Composite (MSFC), fatigue questionnaires, and lower extremity manual muscle testing. Results The most common adverse events were dizziness, insomnia, paresthesia, asthenia, nausea, headache, and tremor. Five subjects were discontinued from Fampridine-SR because of adverse events at doses greater than 25 mg, and these included convulsions in two subjects at doses of 30 and 35 mg twice daily. Improvement were seen in lower extremity muscle strength (prospective analysis) and walking speed (post-hoc analysis) in the Fampridine-SR group compared to placebo (unadjusted p-values of 0.01 and 0.03, respectively). There were no significant differences in other MSFC measure or fatigue scores. Conclusions Future studies should employ doses up to 20 mg twice daily with lower extremity strength and walking speed as potential outcome measures. Multiple Sclerosis 2007; 13: 357-368. http://msj.sagepub.com


2005 ◽  
Vol 11 (2) ◽  
pp. 166-168 ◽  
Author(s):  
U Baumhackl ◽  
L Kappos ◽  
E W Radue ◽  
P Freitag ◽  
A Guseo ◽  
...  

Oral administration of hydrolytic enzymes (HE), such as bromelain, trypsin and rutosid, may have beneficial effects on the clinical course of neurological symptoms related to multiple sclerosis (MS). This is supported by a complete protection by HE from experimental allergic encephalomyelitis, an animal model related to MS. Three hundred and one patients with relapsing MS were enrolled in a double-blind, placebo-controlled trial. No treatment effect between the placebo and the HE groups was found either for clinical or MRI parameters.


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