59 results
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).
Protocol version Amendment 1, 31-Jul-2015, paragraph 2.1, page 28:Primary objective:The primary objective is to assess the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.Secondary objectives:* Evaluation of…
The main objective of this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG). The secondary objectives are to determine if vaccination…
Patients with ALS are routinely prescribed riluzole, the only registered drug for the treatment of ALS. This study will evaluate the concentration-effect relationship of riluzole (100 mg) and retigabine (300 mg) on axonal excitability measures. In…
Primary Objective:* To evaluate the safety and tolerability of ARGX-113.Secondary Objectives:* To evaluate the clinical effect of ARGX-113 using:-Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.-Quantitative-Myasthenia Gravis score (QMG…
The main objective of this pilot study of n-of-one trials is to determine the effect of add-on treatment with ephedrine for all participants enrolled in this small series of n-of-one trials. Secondary objectives include determining the effect in…
Primary objectives: 1. Does vitamin D supplementation improve depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and functional limitations in older persons?Secondary objectives: 3. Does vitamin D…
Primary objectiveThe primary objective is to evaluate the effectiveness of a standardized PT program according to the treatment guideline on improvement of the ability to perform daily life tasks compared to regular PT as add-on treatment to BTX-…
To evaluate the effectiveness and cost-effectiveness of Energetic. Secondary objectives include evaluation of barriers and facilitators for implementation of Energetic in other settings.
The primary objective of this proof of principle study is to determine the effect of levosimendan on the strength and endurance of the diaphragm in healthy subjects. The secondary objective is to gain insight in the neural activation and efficiency…
Primary Objective: (1) To study the efficacy of exercise therapy and CBT for reducing fatigue and improving activities and HRQoL in patients with PPS. Secondary Objectives: (2) To identify generic and disease-specific determinants of effects.(3) To…
(1) To study the efficacy of AET for improving activities and QoL in patients with ALS. (2) To identify generic and disease-specific determinants of effects. (3) To obtain insight into patients* , partners* and professionals' expectations of…
Primary: to assess the effect of intravenous (IV) ozanezumab (15 mg/kg once every 2 weeks) compared to placebo on the physical function and survival of ALS patients over a treatment period of 48-weeks.Secondary (major): other clinical outcomes,…
Primary:The primary objective of the study is to evaluate the efficacy of oral administration of dexpramipexole 150 mg twice daily compared to placebo for 12 months in subjects with ALS.Secondary:The secondary objectives of the study are to evaluate…
The primary objective of this trial will be to evaluate the effect of ONO-2506PO (1200 mg once daily) on the slope of respiratory function (slow vital capacity (SVC) expressed as a percentage of the predicted value) over 12 months compared with…
To compare group medical appointment as a novel approach in care for chronic neuromuscular patients with conventional outpatient visits, in terms of health outcomes and costs.
To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.
Primary Objective:To assess whether the clinical efficacy of RPC1063 is superior to interferon (IFN) *-1a (Avonex®) inreducing the rate of clinical relapses in patients with RMS.Secondary Objectives:- To assess the effect of RPC1063 on the…
The primary objective of this study will investigate the effect of oral levosimendan on the respiratory function of patients with Amyotrophic Lateral Sclerosis.