Investigators assess the diagnostic value of 2 CSF biomarkers to distinguish pediatric acquired demyelinating syndromes from non-acquired demyelinating syndromes.
The NDA resubmission is in response to the FDA's Complete Response Letter issued in 2011 which requested an improved understanding of the safety risks and overall benefit-risk profile.
The combination of genetics and exposure to organic solvents in paints and varnishes increases the risk of multiple sclerosis.
Brain volume loss has nonlinear dynamics and limited reproducibility as a marker of therapeutic response in multiple sclerosis.
Reduced Disability Progression, Adverse Events Top Considerations When Selecting Multiple Sclerosis TherapyJune 08, 2018
A majority of the respondents in both groups identified reduced disability progression as a priority.
A combination of dalfampridine extended-release and physical therapy (PT) has shown efficacy for improving gait in people with multiple sclerosis
Pain in patients with multiple sclerosis may affect their daily functioning regardless of disease severity.
Differing formulations and ratios of the subjects' medical cannabis regimens have been accounted for, though further information about ratios of CBD and TCH are subject to change due to continued ongoing research.
Investigators assessed the effect of disease-modifying treatments on pain in patients with relapsing-remitting multiple sclerosis.
The MS and monophasic ADS groups were compared using quantified melanin measurements via the DSM II Colorimeter; self-reported skin tones of fair, medium, olive, or dark; a self-reported race; and skin tone, which was self-reported using 10 numerical panels of color.
The protocol authors propose a more objective method of managing medication adherence through a profile performed by an occupational therapist.
This study analyzed results from SUNBEAM (ClinicalTrials.gov Identifier: NCT02294058) and RADIANCE (ClinicalTrials.gov Identifier: NCT01628393), 2 double-blind, randomized, phase 3 trials.
Immunotherapy in multiple sclerosis may increase the risk for conversion from latent to active tuberculosis infection.
The study researchers examined data from the US database of the IMS Health Real World Data Adjudicated Claims between 2011 and 2015.
Alemtuzumab is associated with reduced magnetic resonance imaging disease activity and the slowing of brain volume loss over 7 years in patients with relapsing-remitting multiple sclerosis.
Cognitive impairment is common in patients with multiple sclerosis (MS) and considerably impacts quality of life.
Due to the increased risk for urinary tract infections (UTIs) in people with MS and similar CNS demyelinating diseases, as well as the tendency of UTIs to trigger more MS flares, the affected population are subject to a large number of unneeded antibiotic prescriptions and asymptomatic bacteriuria treatments.
Brain volume loss was smaller for all groups after treatment with fingolimod.
TG1101-RMS201 was a multicenter, placebo-controlled, phase 2, 52-week study designed to evaluate the optimal infusion and safety of ublituximab for relapsing multiple sclerosis.
The VELOCE trial (ClinicalTrials.gov Identifier: NCT02545868) was an open-label, randomized, phase 3b study designed to assess whether ocrelizumab could raise the humoral responses to vaccines in individuals with relapsing multiple sclerosis.
This retrospective cohort study sought to assess the outcomes for individuals with multiple sclerosis who transitioned from natalizumab to dimethyl fumarate.
The multiple-logistic regression analyses determined that the most consistent predictors for negative clinical outcomes in months 12 to 48 were relapses during months 0 to 12 and EDSS scores at baseline and months 0 to 12.
Analysis of yearly lymphocyte counts showed a declining occurrence of all grades of lymphopenia over time, and by year 9, subjects exhibited no cases of lymphopenia.
The investigators examined the association between obesity and the age of first symptom(s), number of impaired functional domains, and early relapse activity in patients with MS.
Patients with higher rates of depression and fatigue were significantly more likely to have lower MMAS-8 adherence scores.
A prospective, blinded, randomized trial comparing once-weekly and twice-weekly IM IFNβ-1a may be indicated.
Although the study demonstrated a lower relapse rate among patients with MS who supplemented their diet with vitamin D, the analysis did not reach statistical significance.
Investigators explored the efficacy and safety of alemtuzumab in patients initially assigned to alemtuzumab in a previous trial followed by alemtuzumab treatment over a 2-year period in a core study plus an additional 4-year period in an extension trial.
Various clinical symptoms precede the diagnosis of multiple sclerosis by several years.
The FDA's decision was based on data from the Phase 3 PARADIGMS study (N=215) which evaluated the safety and efficacy of oral fingolimod vs interferon beta-1a injection in pediatric patients aged 10 to <18 years with relapsing MS.
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