scholarly journals MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study

CNS Drugs ◽  
2018 ◽  
Vol 32 (7) ◽  
pp. 661-672 ◽  
Author(s):  
Ayman Tourbah ◽  
Olivier Gout ◽  
Alain Vighetto ◽  
Véronique Deburghgraeve ◽  
Jean Pelletier ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Optic Neuritis ◽  
Visual Loss ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study

2016 ◽  
Vol 22 (13) ◽  
pp. 1719-1731 ◽  
Author(s):  
Ayman Tourbah ◽  
Christine Lebrun-Frenay ◽  
Gilles Edan ◽  
Michel Clanet ◽  
Caroline Papeix ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Primary Endpoint ◽  
Progressive Multiple Sclerosis ◽  
Controlled Study ◽  
Clinical Impression ◽  
High Dose ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Disability Status

Background: Treatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study. Objective: To confirm the efficacy and safety of MD1003 in progressive MS in a double-blind, placebo-controlled study. Methods: Patients ( n = 154) with a baseline Expanded Disability Status Scale (EDSS) score of 4.5–7 and evidence of disease worsening within the previous 2 years were randomised to 12-month MD1003 (100 mg biotin) or placebo thrice daily, followed by 12-month MD1003 for all patients. The primary endpoint was the proportion of patients with disability reversal at month 9, confirmed at month 12, defined as an EDSS decrease of ⩾1 point (⩾0.5 for EDSS 6–7) or a ⩾20% decrease in timed 25-foot walk time compared with the best baseline among screening or randomisation visits. Results: A total of 13 (12.6%) MD1003-treated patients achieved the primary endpoint versus none of the placebo-treated patients ( p = 0.005). MD1003 treatment also reduced EDSS progression and improved clinical impression of change compared with placebo. Efficacy was maintained over follow-up, and the safety profile of MD1003 was similar to that of placebo. Conclusion: MD1003 achieves sustained reversal of MS-related disability in a subset of patients with progressive MS and is well tolerated.

Treatment of relapsing-remittent multiple sclerosis with recombinant human interferon-alfa-2a: design of a randomised, placebo-controlled, double blind trial in Norway

1996 ◽  
Vol 1 (6) ◽  
pp. 372-375 ◽  
Author(s):  
H Nyland ◽  
K-M Myhr ◽  
F Lillås ◽  
AI Smievoll ◽  
T Riise ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Primary Objective ◽  
Interferon Alfa ◽  
Controlled Study ◽  
Human Interferon ◽  
New Disease ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Drug Free

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.

Treatment of spasticity with repetitive magnetic stimulation; a double-blind placebo-controlled study

1996 ◽  
Vol 2 (5) ◽  
pp. 227-232 ◽  
Author(s):  
Jorgen F Nielsen ◽  
Thomas Sinkjaer ◽  
Johannes Jakobsen
Keyword(s):  
Multiple Sclerosis ◽  
Stretch Reflex ◽  
Magnetic Stimulation ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Future Studies ◽  
Sham Stimulation ◽  
Repetitive Magnetic Stimulation ◽  
Reflex Threshold

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.

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