scholarly journals Evaluating the Role of Corticosteroid Pulse Therapy in Patients With Secondary Progressive Multiple Sclerosis Receiving Mitoxantrone: A Double Blind Randomized Controlled Clinical Trial

2015 ◽  
Vol 17 (10) ◽  
Author(s):  
Abolghasem Rahimdel ◽  
Ahmad Zeinali ◽  
Ali Mellat
Keyword(s):  
Multiple Sclerosis ◽  
Pulse Therapy ◽  
Progressive Multiple Sclerosis ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Secondary Progressive ◽  
Randomized Controlled ◽  
Corticosteroid Pulse Therapy

A double-blind, randomized, controlled study of oral pirfenidone for treatment of secondary progressive multiple sclerosis

2005 ◽  
Vol 11 (2) ◽  
pp. 149-158 ◽  
Author(s):  
Jonathan E Walker ◽  
Shri N Giri ◽  
Solomon B Margolin
Keyword(s):  
Multiple Sclerosis ◽  
Rating Scale ◽  
Progressive Multiple Sclerosis ◽  
Secondary Progressive Multiple Sclerosis ◽  
Bladder Function ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Secondary Progressive ◽  
Randomized Controlled

Currently, there are no approved treatments for secondary progressive multiple sclerosis (MS) that stabilize or reverse the neurological disabilities associated with this disease. Oral pirfenidone was found to stabilize and overcome the disabilities in two published independent open-label studies in secondary progressive MS. This led us to study pirfenidone in a phase II double-blind, randomized and controlled, clinical trial in patients with advanced secondary progressive MS for 12 months. Forty-three patients met the eligibility criteria approved by the IRB and accepted by the FDA. Of these patients, 18 were randomly assigned to placebo and 25 patients to oral pirfenidone groups. All eligible patients were included in the statistical analysis of the data according to intention-to-treat principles. Some patients on oral pirfenidone manifested mild drug-related adverse effects, but it was well tolerated overall. By one month, pirfenidone significantly (P<0.05) improved the Scripps Neurological Rating Scale (SNRS) scores, and scores remained significantly improved for 3, 6 and 12 months when compared to the baseline SNRS scores. In contrast, the SNRS scores of patients on oral placebo were not significantly improved at 1, 3, 6 or 12 months of the study, when compared with baseline scores. Oral pirfenidone significantly (P<0.04) reduced the incidence of relapses (27.8% on placebo versus 8.0% on pirfenidone). Furthermore, oral pirfenidone treatment was associated with a marked improvement in bladder dysfunction (40.0% on pirfenidone versus 16.7% on placebo). Expanded Disability Status Scale scores and MRI lesion count were not significantly different in the placebo and pirfenidone groups. These findings indicate a significant effect of pirfenidone on clinical disability and bladder function for secondary progressive MS patients. A major multicentre, double-blind, randomized, controlled trial is justified.

A novel in-home digital treatment to improve processing speed in people with multiple sclerosis: A pilot study

2020 ◽  
pp. 135245852093037
Author(s):  
Riley Bove ◽  
William Rowles ◽  
Chao Zhao ◽  
Annika Anderson ◽  
Samuel Friedman ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Processing Speed ◽  
Control Word ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Point Increase ◽  
Z Scores

Objective: To assess whether a videogame-like digital treatment is superior to a control in improving processing speed in adults with multiple sclerosis (MS). Methods: Adults with MS and baseline Symbol Digit Modalities Test (SDMT) z-scores between −2 and 0 were enrolled in a double-blind randomized controlled clinical trial. After completing a baseline in-clinic evaluation (Visit 1), they were randomized to complete an in-home, tablet-based videogame-like digital treatment (AKL-T03) or control word game (AKL-T09) for up to 25 minutes/day, 5 days/week, for 6 weeks. A repeat in-clinic evaluation occurred at 6 weeks (Visit 2), and again 8 weeks later to determine persistence of effects (Visit 3). The pre-specified primary outcome was change in SDMT score between Visits 1 and 2. Results: SDMT increased at Visit 2 for participants randomized to both AKL-T03 ( p < 0.001) and AKL-T09 ( p = 0.024). These respective mean improvements were +6.10 and +3.55 (comparison p = 0.21). At Visit 3, 70% of participants randomized to AKL-T03 maintained a clinically meaningful 4+-point increase in SDMT above their baseline, compared with 37% for AKL-T09 ( p = 0.038). Conclusion: This in-home digital intervention resulted in substantial and durable improvements in processing speed. A larger randomized controlled clinical trial is planned. Trial Registration: This trial is registered on ClinicalTrials.gov under “NCT03569618,” https://clinicaltrials.gov/ct2/show/NCT03569618 .

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