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Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential

, Germany; Tjalf Ziemssen, Universitätsklinikum Carl Gustav Carus, Dresden, Germany; Giancarlo Comi, Ospedale San Raffaele S.r.l., Milan, Italy; Bernardo Sánchez Dalmau, Institut Biomedical Research August Pi ... submitted work. Tjalf Ziemssen has received consulting fees from Almirall, Bayer HealthCare, Biogen, Genzyme, GlaxoSmithKline, Merck Serono, MSD, Novartis, Sanofi-Aventis, Synthon, and Teva; and research

Two studies in one: A propensity-score-matched comparison of fingolimod versus interferons and glatiramer acetate using real-world data from the independent German studies, PANGAEA and PEARL

Background This study compared outcomes following fingolimod or BRACE treatments (beta-interferons/glatiramer acetate) in patients with active MS (≥ 1 relapse in the previous year) following previous BRACE treatment. Methods and findings Patients with active MS who previously received BRACE were identified from German prospective, observational studies, PANGAEA and PEARL. A novel...

Subthalamic nucleus stimulation and levodopa modulate cardiovascular autonomic function in Parkinson’s disease

We aimed to explore the effects of bilateral subthalamic nucleus stimulation and levodopa on cardiovascular autonomic function in Parkinson’s disease. Twenty-six Parkinson’s disease patients with bilateral subthalamic nucleus stimulation in a stable state were tested under stimulation off and dopaminergic medication off (OFF-OFF), stimulation on and dopaminergic medication off...

Study design of PANGAEA 2.0, a non-interventional study on RRMS patients to be switched to fingolimod

final manuscript. Competing interests Tjalf Ziemssen has served on scientific advisory boards, and has received scientific grants and speaker honoraria from Bayer, Biogen Idec, Genzyme, TEVA, Merck

Multiple sclerosis: clinical profiling and data collection as prerequisite for personalized medicine approach

. Competing interests Tjalf Ziemssen has received reimbursements for participation in scientific advisory boards from Bayer Healthcare, Biogen Idec, Novartis Pharma AG, Merck Serono, Teva, Genzyme, and Synthon

The importance of collecting structured clinical information on multiple sclerosis

Background Randomized controlled trials (RCTs) are the ‘gold standard’ in the generation of drug efficacy and safety evidence. However, enrolment criteria, timelines and atypical comparators of RCTs limit their relevance to standard clinical practice. Discussion Real-world data (RWD) provide longitudinal information on the comparative effectiveness and tolerability of drugs, as...

Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit–Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA

, Neurological University Clinic Carl Gustav Carus, University of Technology , Dresden , Germany 3 Tjalf Ziemssen 4 Novartis Pharma AG , Basel , Switzerland 5 Kassel and Vellmar Neurological Practice , Vellmar

Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate

glatiramer acetate Tjalf Ziemssen 0 Yossi Gilgun-Sherki 1 0 Center of Clinical Neuroscience, Neurological University Clinic, University Clinic Carl Gustav Carus, University of Technology Dresden

The PANGAEA study design – a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice

Tjalf Ziemssen has served on scientific advisory boards, and has received scientific grants speaker honoraria from Bayer, Biogen Idec, Genzyme, TEVA, Merck Serono and Novartis. Christian Cornelissen is an ... Ziemssen 0 Raimar Kern 0 Christian Cornelissen 0 Zentrum für klinische Neurowissenschaften, Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus Dresden, Technische Universität

Rationale, design, and methods of a non-interventional study to establish safety, effectiveness, quality of life, cognition, health-related and work capacity data on Alemtuzumab in multiple sclerosis patients in Germany (TREAT-MS)

this manuscript. Competing interests Tjalf Ziemssen has served on scientific advisory boards, and has received scientific grants speaker honoraria from Bayer, Biogen Idec, Genzyme, TEVA, Merck Serono

Patient Satisfaction with the New Interferon Beta-1b Autoinjector (BETACONNECT™)

IntroductionMultiple sclerosis (MS) typically requires life-long management with disease-modifying therapies (DMTs). Many DMTs require regular self-injection, and can be associated with injection site reactions, pain, and needle/injection phobia—but these can be addressed by improvements in autoinjector design. The aim of this study was to investigate patient satisfaction and...

Optimizing treatment success in multiple sclerosis

Neuroscience, Neurological Clinic, University Hospital Carl Gustav Carus, Dresden University of Technology , Fetscherstrasse 74, 01307 Dresden , Germany 2 & Tjalf Ziemssen 3 Department of Neurology ... . There is no relevant conflict of interest for all authors. Tjalf Ziemssen has received reimbursements for participation in scientific advisory boards, research support and speaker honorarium from Almirall

Fingolimod in a patient with heart failure on the background of pulmonary arterial hypertension and coronary artery disease

Background Fingolimod is the first oral immunomodulatory therapy approved for highly active relapsing remitting multiple sclerosis. Based on the distribution pattern of fingolimod interacting sphingosine-1-phosphat receptors in organism including immune system and cardiovascular system clinical monitoring of patients and evaluation of adverse events are recommended. Despite...

Design of TRUST, a non-interventional, multicenter, 3-year prospective study investigating an integrated patient management approach in patients with relapsing-remitting multiple sclerosis treated with natalizumab

Background Natalizumab provides rapid and high-efficacy control of multiple sclerosis disease activity with long-term stabilization. However, the benefits of the drug are countered by a risk of developing progressive multifocal leukoencephalopathy in patients infected with the John Cunningham Virus. Close monitoring is required in patients with increased progressive multifocal...

Cortisol Awakening Response Is Linked to Disease Course and Progression in Multiple Sclerosis

Objectives Dysregulation of the hypothalamus-pituitary-adrenal (HPA) axis has frequently been reported in multiple sclerosis (MS). So far, HPA axis function in MS has predominantly been studied under pharmacological stimulation which is associated with a series of methodological caveats. Knowledge of circadian cortisol patterns and cortisol awakening response (CAR) is still...

Improving patient–physician dialog: commentary on the results of the MS Choices survey

“Fondazione Cesare Serono.” Tjalf Ziemssen has received speaker honoraria from Biogen Idec, Sanof i-Aventis, Merck Serono, MSD, Novartis, Synthon, Teva, and Bayer HealthCare; and serves as a consultant for

Determination of Baroreflex Sensitivity during the Modified Oxford Maneuver by Trigonometric Regressive Spectral Analysis

Background Differences in spontaneous and drug-induced baroreflex sensitivity (BRS) have been attributed to its different operating ranges. The current study attempted to compare BRS estimates during cardiovascular steady-state and pharmacologically stimulation using an innovative algorithm for dynamic determination of baroreflex gain. Methodology/Principal Findings Forty-five...

Trigonometric Regressive Spectral Analysis Reliably Maps Dynamic Changes in Baroreflex Sensitivity and Autonomic Tone: The Effect of Gender and Age

Background The assessment of baroreflex sensitivity (BRS) has emerged as prognostic tool in cardiology. Although available computer-assisted methods, measuring spontaneous fluctuations of heart rate and blood pressure in the time and frequency domain are easily applicable, they do not allow for quantification of BRS during cardiovascular adaption processes. This, however, seems...

Effects of glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis

Objectives Treatment of multiple sclerosis patients with glatiramer acetate has been demonstrated a beneficial effect on disease activity. The objective of this prospective naturalistic study was to evaluate the impact of glatiramer acetate on fatigue and work absenteeism. Methods 291 treatment-naïve patients with relapsing remitting multiple sclerosis were included and treated...