scholarly journals Enrollment in a Multiple Sclerosis Clinical Trial: The EVIDENCE Experience

2004 ◽  
Vol 6 (1) ◽  
pp. 23-25
Author(s):  
Edward Monaghan ◽  
Marylou Basile ◽  
Olympia Hadjimichael ◽  
Timothy L. Vollmer ◽  
Gordon S. Francis

This paper describes the methods used to recruit patients for the EVIDENCE (EVidence for Interferon Dose-Effect: European-North American Comparative Efficacy) study, and the results of that recruitment. The majority of enrolled patients came from the investigators' clinic populations, with an additional 30% entering the study as a result of specific recruitment efforts. Local efforts, including referrals from colleagues, postings on bulletin boards, contacts with local Multiple Sclerosis Society chapters and newspaper advertisements, were the most successful recruitment tools. Mass mailings to local neurologists, referrals from a national multiple sclerosis registry, Web sites, and radio or television spots were less effective in recruiting eligible patients.

2020 ◽  
Author(s):  
Marcello De Angelis ◽  
Luigi Lavorgna ◽  
Antonio Carotenuto ◽  
Martina Petruzzo ◽  
Roberta Lanzillo ◽  
...  

BACKGROUND Clinical trials in multiple sclerosis (MS) have leveraged the use of digital technology to overcome limitations in treatment and disease monitoring. OBJECTIVE To review the use of digital technology in concluded and ongoing MS clinical trials. METHODS In March 2020, we searched for “multiple sclerosis” and “trial” on pubmed.gov and clinicaltrials.gov using “app”, “digital”, “electronic”, “internet” and “mobile” as additional search words, separately. Overall, we included thirty-five studies. RESULTS Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Also, digital technology has become increasingly used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms. Some trials have been developing new patient-centred outcome measures for the detection of symptoms and of treatment side effects and adherence. CONCLUSIONS We will discuss how digital technology has been changing MS clinical trial design, and possible future directions for MS and neurology research.


2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Maurice A. Canham ◽  
John D. M. Campbell ◽  
Joanne C. Mountford

Abstract More than seven months into the coronavirus disease -19 (COVID-19) pandemic, infection from the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has led to over 21.2 million cases and resulted in over 760,000 deaths worldwide so far. As a result, COVID-19 has changed all our lives as we battle to curtail the spread of the infection in the absence of specific therapies against coronaviruses and in anticipation of a proven safe and efficacious vaccine. Common with previous outbreaks of coronavirus infections, SARS and Middle East respiratory syndrome, COVID-19 can lead to acute respiratory distress syndrome (ARDS) that arises due to an imbalanced immune response. While several repurposed antiviral and host-response drugs are under examination as potential treatments, other novel therapeutics are also being explored to alleviate the effects on critically ill patients. The use of mesenchymal stromal cells (MSCs) for COVID-19 has become an attractive avenue down which almost 70 different clinical trial teams have ventured. Successfully trialled for the treatment of other conditions such as multiple sclerosis, osteoarthritis and graft versus host disease, MSCs possess both regenerative and immunomodulatory properties, the latter of which can be harnessed to reduce the severity and longevity of ARDS in patients under intensive care due to SARS-CoV-2 infection.


Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.


2014 ◽  
Vol 72 (2) ◽  
pp. 152-156 ◽  
Author(s):  
Doralina Guimarães Brum ◽  
Elizabeth Regina Comini-Frota ◽  
Claúdia Cristina F. Vasconcelos ◽  
Elza Dias-Tosta

Multiple sclerosis (MS) is an inflammatory, autoimmune, demyelinating, and degenerative central nervous system disease. Even though the etiology of MS has not yet been fully elucidated, there is evidence that genetic and environmental factors interact to cause the disease. Among the main environmental factors studied, those more likely associated with MS include certain viruses, smoking, and hypovitaminosis D. This review aimed to determine whether there is evidence to recommend the use of vitamin D as monotherapy or as adjunct therapy in patients with MS. We searched PUBMED, EMBASE, COCHRANNE, and LILACS databases for studies published until September 9 th , 2013, using the keywords “multiple sclerosis”, “vitamin D”, and “clinical trial”. There is no scientific evidence up to the production of this consensus for the use of vitamin D as monotherapy for MS in clinical practice.


Physiotherapy ◽  
2021 ◽  
Author(s):  
Juan de Dios Pérez-Bruzón ◽  
César Fernández-de-las-Peñas ◽  
Joshua A. Cleland ◽  
Gustavo Plaza-Manzano ◽  
Ricardo Ortega-Santiago

2001 ◽  
Vol 37 (2) ◽  
pp. 300-307 ◽  
Author(s):  
Chaim Charytan ◽  
Nathan Levin ◽  
Mourhege Al-Saloum ◽  
T. Hafeez ◽  
Suzanne Gagnon ◽  
...  

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