Intravenous immunoglobulin (IVIG) treatment for patients with primary or secondary progressive multiple sclerosis - outline of a double-blind randomized, placebo-controlled trial

1997 ◽  
Vol 3 (2) ◽  
pp. 149-152 ◽  
Author(s):  
D. Poehlau ◽  
J. Federlein ◽  
T. Postert ◽  
M. Sailer ◽  
F. Bethke ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Progressive Multiple Sclerosis ◽  
Phase Iii ◽  
Ivig Treatment ◽  
Double Blind ◽  
Disability Status ◽  
Chronic Progressive Multiple Sclerosis ◽  
Phase Iii Study ◽  
Two Measures

We present the design of a double-blind, randomised placebo-controlled phase III study to evaluate safety and efficacy of IVIG in the treatment of patients suffering from primary or secondary chronic progressive multiple sclerosis. The primary endpoint is disability. Two measures of disability were chosen in order to assess the primary end point: (a) sustained improvement (assessed at month 6, confirmed at month 9) and (b) progression to increasing disability of the disease (sustained for 3 months) at any time during the course of this 2 years study. The disability is measured by the Extended Disability Status Scale (EDSS). Secondary end points include the assessment of visual function, functions of the upper extremity, cognitive functions, depression and quality of life.

A double-blind, placebo-controlled trial of extracorporeal photopheresis in chronic progressive multiple sclerosis

1999 ◽  
Vol 5 (3) ◽  
pp. 198-203 ◽  
Author(s):  
A M Rostami ◽  
R A Sater ◽  
S J Bird ◽  
S Galetta ◽  
R E Farber ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Progressive Multiple Sclerosis ◽  
Plaque Burden ◽  
Extracorporeal Photopheresis ◽  
Double Blind ◽  
Definite Multiple Sclerosis ◽  
Chronic Progressive Multiple Sclerosis ◽  
Clinically Definite Multiple Sclerosis ◽  
Double Blinded

Extracorporeal photopheresis is a safe therapy for cutaneous T-cell lymphoma and may have efficacy in certain autoimmune disorders. We performed a randomized, double-blinded, placebo-controlled trial of monthly photopheresis therapy in 16 patients with clinically definite multiple sclerosis (MS). All patients had progressed during the preceding year with entry Expanded Disability Status Scale (EDSS) scores between 3.0 and 7.0. Patients received photopheresis or sham therapy for 1 year and were followed for an additional 6 to 12 months. Patients were clinically evaluated by three disability scales: (1) EDSS; (2) Ambulation index and (3) Scripp's quantitative neurologic assessment. No serious side effects occurred in either group. There were no differences between the photopheresis and sham therapy groups by the disability measures. Additionally, there were no differences in progression of MRI plaque burden or evoked potential latencies. In this limited study, photopheresis was found to be safe but did not significantly alter the course of chronic progressive MS.

scholarly journals Safety and Tolerability of Subcutaneous Cladribine Therapy in Progressive Multiple Sclerosis

1998 ◽  
Vol 25 (4) ◽  
pp. 295-299 ◽  
Author(s):  
R. Selby ◽  
J. Brandwein ◽  
P. O'Connor
Keyword(s):  
Multiple Sclerosis ◽  
Lymphocyte Count ◽  
Antineoplastic Agent ◽  
Absolute Lymphocyte Count ◽  
Progressive Multiple Sclerosis ◽  
Disability Status ◽  
Chronic Progressive Multiple Sclerosis ◽  
Clinically Significant ◽  
One Year ◽  
Post Therapy

ABSTRACT:Objective:To evaluate the safety and tolerability of subcutaneous (s.c.) cladribine therapy in patients with chronic progressive multiple sclerosis (CPMS), and to evaluate the effects on lymphocyte subsets.Background:Cladribine, a synthetic antineoplastic agent with immunosuppressive effects, may favourably affect the course of CPMS. However results of a previous reported clinical trial showed significant myelosuppression in some patients.Design/Methods:19 patients with severe (mean extended disability status score [EDSS] = 6.7) CPMS were treated on a compassionate basis with cladribine 0.07 mg/kg/ day s.c. for 5 days per cycle, repeated every 4 weeks for a total of 6 cycles. Patients underwent clinical evaluation, EDSS, and hematologic analysis before, during, and following therapy.Results:The treatment was very well tolerated with no clinically significant side effects observed. Between baseline and the end of cycle 6, mean decreases were noted in absolute lymphocyte count from 1697 to 463 (p = 0.000012), CD4 count from 865 to 187 (p = 0.0000008), CD8 from 418 to 165 (p = 0.005) and CD19 from 197 to 26 (p = 0.000002). Platelet, granulocyte and RBC counts were unaffected. Approximately one year after completion of therapy, some recovery of CD4 and CD8 counts had occurred although both counts remained suppressed compared to baseline (302 and 227 respectively); the CD19 count had recovered essentially to normal by one year. EDSS scores post-therapy revealed some deterioration in 8 patients and stable scores in the remaining 11. Global patient evaluations of the treatment were mixed.Conclusions:Cladribine therapy, at lower doses than previously reported, was remarkably well tolerated in CPMS, with no significant myelosuppression. Profound effects occurred in total lymphocyte count and CD4, CD8 and CD19 subsets.

scholarly journals Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial

2018 ◽  
Vol 24 (14) ◽  
pp. 1862-1870 ◽  
Author(s):  
Edward J Fox ◽  
Clyde Markowitz ◽  
Angela Applebee ◽  
Xavier Montalban ◽  
Jerry S Wolinsky ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Upper Extremity ◽  
Progressive Multiple Sclerosis ◽  
Phase Iii ◽  
Primary Progressive Multiple Sclerosis ◽  
Primary Progressive ◽  
Intention To Treat ◽  
Disability Status ◽  
Upper Extremity Impairment ◽  
Post Hoc

Background: Upper extremity (UE) impairment is common with primary progressive multiple sclerosis (PPMS). Objective: This exploratory analysis examined the effects of ocrelizumab on confirmed progression (CP) and confirmed improvement (CI) in UE impairment in patients from ORATORIO. Methods: Patients with PPMS received ocrelizumab 600 mg or placebo every 24 weeks for ⩾120 weeks. The Nine-Hole Peg Test (9HPT) was administered at baseline (BL) and every 12 weeks thereafter. Prespecified exploratory endpoints included change in 9HPT time and proportion of patients with CP of ⩾20% in 9HPT. Analysis populations included intention-to-treat (ITT) patients and subgroups stratified by BL 9HPT time and Expanded Disability Status Scale. Post hoc analyses included the proportion of patients achieving more severe thresholds of CP and the proportion achieving CI in 9HPT. Results: Among ITT patients, ocrelizumab significantly reduced the change in 9HPT time over 120 weeks, the risk of CP of ⩾20% in 9HPT time for both hands and the risk of more severe 9HPT progression versus placebo. Numerical trends also favoured ocrelizumab versus placebo with respect to achieving CI. Consistent directional trends were observed in subgroup analyses. Conclusion: Ocrelizumab reduces the risk of UE disability progression and may increase the possibility of improvement versus placebo in PPMS.

A double-blind, cross-over trial of intravenous immunoglobulin G in multiple sclerosis: Preliminary results

1997 ◽  
Vol 3 (2) ◽  
pp. 145-148 ◽  
Author(s):  
P. Soelberg Sørensen ◽  
B. Wanscher ◽  
K. Schreiber ◽  
M. Blinkenberg ◽  
C.V. Jensen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Intravenous Immunoglobulin ◽  
Immunoglobulin G ◽  
Progressive Multiple Sclerosis ◽  
Ivig Treatment ◽  
Double Blind Study ◽  
Intravenous Methylprednisolone ◽  
Double Blind ◽  
Relapsing Remitting ◽  
Intravenous Immunoglobulin G

We enrolled 25 patients with relapsing-remitting or relapsing progressive multiple sclerosis (MS) in a randomized placebo-controlled double-blind study of intravenous immunoglobulin G (IVIG). IVIG Iglkg daily for 2 days was administered every 4 weeks for 24 weeks. Seventeen patients completed the whole trial, whereas eight patients discontinued the trial; four during IVIG treatment and four on placebo. Of the 17 patients who completed the trial, II had no exacerbations during IVIG treatment compared with only six on placebo (P=0.05). The total number of exacerbations in the IVIG period was I / and in the placebo period 15 (NS), and the number of severe exacerbations requiring treatment with intravenous methylprednisolone was four during treatment with IVIG and six on placebo (NS). The results suggest that IVIG treatment may be of beneft for prevention of exacerbations in patients with relapsing MS.

Riboflavin Supplementation to Patients with Multiple Sclerosis does not Improve Disability Status nor is Riboflavin Supplementation Correlated to Homocysteine

2013 ◽  
Vol 83 (5) ◽  
pp. 281-290 ◽  
Author(s):  
Mahshid Naghashpour ◽  
Nastaran Majdinasab ◽  
Ghodratollah Shakerinejad ◽  
Maryam Kouchak ◽  
Mohammad H. Haghighizadeh ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Demyelinating Disease ◽  
Reductase Activity ◽  
Controlled Trial ◽  
Riboflavin Deficiency ◽  
Double Blind ◽  
Serum Homocysteine ◽  
Study Results ◽  
Disability Status ◽  
Before And After

Background: Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system. Riboflavin is involved in myelin formation in nerve cells. Riboflavin is a precursor of flavin adenine D-nucleotide (FAD), which is a coenzyme of methylene tetrahydrofolate reductase (MTHFR), which is an important enzyme for remethylation of homocysteine. Riboflavin supplementation has been shown to affect the serum levels of homocysteine in healthy volunteers. The aim of the present study was to test the effect of riboflavin supplementation on the status and disability of patients with MS and whether this effect could be mediated by serum homocysteine levels. Materials and Methods: This was a randomized, double-blind, controlled trial in which 29 MS patients with a mean age of 33 were tested with riboflavin, and the placebo group, with a mean age of 31, received either riboflavin supplementation (10 mg) or the placebo daily for six months. Disability, measured by the Expanded Disability Status Scale (EDSS) scores, erythrocyte glutathione reductase activity coefficient (EGRAC), and serum homocysteine levels were measured before and after the study. Results: The mean ± SD of EDSS score was significantly decreased in both groups over the six months of the study (2.3 ± 0.7 vs. 1.6 ± 0.6 for the riboflavin group and 2.8 ± 1.1 vs. 2.3 ± 1.3 for the placebo groups. The comparison across both groups yielded a non-significant change (P = 0.001 and 0.02, respectively). No significant differences were observed between the two groups in terms of EGRAC, riboflavin deficiency levels by EGRAC category, and serum homocysteine levels before and after the study. Conclusion: Riboflavin supplementation (10 mg/day) to patients with MS does not improve disability status. It appears that this effect is not related to serum homocysteine levels.

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