
Multiple Sclerosis and Pilates
Multiple SclerosisPilates is becoming popular among the multiple sclerosis (MS) community as an alternative to the more traditional exercise programs. Although somewhat limited, previous research has suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded, randomized controlled study has one intervention group (Pilates and massage therapy) and one control group (massage therapy only). The primary outcome of interest is the change in walking ability between groups. Secondary outcomes include other measures of physical performance and quality of life.

Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic...
Systemic Sclerosis Patients With Digital UlcersEfficacy and safety of local infusion of botulinum toxin type B in patients with systemic sclerosis (SSc) with digital ulcer is evaluated by a randomized, double-blind study.

Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis Patients
Motor Neuron DiseaseBackground: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that selectively affects motor neurons in the brain and spinal cord, leading to bulbar, respiratory, and limb weakness. There is no effective treatment, and the disease usually progresses to death within 2 to 4 years. The therapeutic plasticity of mesenchymal stem cells (MSCs) may be an attractive therapy to this complex disease, turning MSCs strong candidates for cellular therapy in ALS. Design-A phase 1 open-safety clinical trial. 4 patients will be selected according to a restricted inclusion and exclusion criteria and after 2 escalated infusions of MSCs, there will be a follow up period of one year Methods - Primary endpoint: safety of mesenchymal autologous stem cells infusions escalated in two intrathecal administrations in patients with ALS defined as severe adverse events (SAe). Secondary endpoints: clinical response, laboratorial and magnetic resonance imaging of patients submitted to cellular escalating doses applied in the study. Quality of life, according to El Escorial criteria, ALSFR scale and functional scales. Conclusion: This study is a primary step before a large randomized double-blind clinical trial for ALS. It is expected to confirm the safety of escalated MSCs therapy in ALS patients, initial data of efficacy in addition to improved quality of life.

A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia
Multiple SclerosisFatigue1 moreThis study assesses the safety, tolerability, and efficacy of suvorexant in multiple sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater improvement in sleep, as measured by symptom rating scales, compared to placebo.

Abdominal Massage for Bowel Dysfunction
Multiple SclerosisThe aim of the AMBER trial is to determine the effectiveness and cost effectiveness of abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who have problems with their bowel i.e. faecal incontinence and/or constipation.

Early Exercise Efforts in Multiple Sclerosis
Multiple SclerosisThis study seeks to investigate whether early exercise efforts can expand the use of exercise in Multiple sclerosis (MS), from symptom treatment only, to early supplementary disease-modifying treatment. The study will be conducted in a randomized and controlled manner, with single blinding. Participants will be allocated to either a systematic aerobic exercise intervention or an educational programme on exercise and physical activity. Both interventions will last 1 year, and involve a 1 year follow-up period. It is hypothesized that early exercise efforts can modify the disease activity and disability progression.

A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With...
Multiple SclerosisSpasticity1 moreSpasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS.

Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression. Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.

Phase 1 Dose Escalation and PK Study of Cu(II)ATSM in ALS/MND
Amyotrophic Lateral SclerosisMotor Neuron DiseaseMulticenter, open-label , single and multiple dose-escalation and pharmacokinetic study

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
Systemic SclerosisPrimary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives: To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc. To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc. To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc. To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc. To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.