Effects of Blood Flow Restriction Training on Middle-aged People With Multiple Sclerosis.
SclerosisMultipleTo analyze the effects of a resistance training program based on the blood flow restriction modality on muscle strengthening and functionality in people over 45 years of age with multiple sclerosis (MS).
Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (CLASP-MS).
Multiple SclerosisSecondary Progressive1 moreThe purpose of the study is to evaluate the efficacy and safety of subcutaneously administered cladribine versus placebo to stop inflammation and treat disease progression of non-active secondary progressive multiple sclerosis. Multiple sclerosis is an inflammatory disease of the central nervous system. In most patients, it starts with a relapsing course (RMS) which is caused by acute inflammatory lesions in the brain and spinal cord. RMS transforms at later stages into progressive disease (secondary progressive MS). Currently approved disease-modifying treatments are effective in reducing clinical relapses and brain and spinal lesions visible in MR, but they perform poorly in preventing disease progression and overall disability accumulation. The growing evidence shows that disease progression partially depends on chronic inflammation present in the CNS. Drugs, which may cross the blood-brain barrier and reach inflammatory cells residing in the CNS might be effective in this stage of the disease. Cladribine is one of the DMT approved for RMS. It is a synthetic purine analog with selective lymphocyte toxicity, which enter the CNS and is found in cerebrospinal fluid. In patients treated with cladribine, the oligoclonal bands tend to disappear proving that neuroinflammation is diminished. The participants of this clinical trial with the later non-active stage of MS are enrolled to be treated with cladribine subcutaneously or a non-active comparator (placebo) for 6 months and followed for the next 2 years, with an MRI scan and clinical evaluation every 6 months. The main questions it aims to answer are if in the non-active stage of MS cladribine is potent to lessen brain volume loss and if it is potent to attenuate inflammation in the CNS.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302 in Healthy Volunteers and...
Amyotrophic Lateral SclerosisThe first-in-human Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy...
Tuberous Sclerosis Complex Associated Neuropsychiatric DiseaseThe purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis
Older AdultsMultiple Sclerosis2 moreThe overall objective of the proposed randomized controlled (RCT) is to determine the feasibility and efficacy of a 16-week theory-based, remotely-delivered, combined exercise (aerobic and resistance) training intervention for improving cognitive and physical function in older adults (50+ years) with multiple sclerosis (MS) who have mild-to-moderate cognitive and walking impairment. Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant's home/community and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. It is hypothesized that the home-based exercise intervention will yield beneficial effects on cognition, mobility, physical activity, and vascular function compared with an active control condition (flexibility and stretching intervention), and these improvements will be sustained during a 16-week follow-up period.
Study Protocol of Online DBT-Mindfulness Intervention in Multiple Sclerosis
Multiple SclerosisThe goal of this clinical trial is to test an Online DBT-Mindfulness intervention in people with Multiple Sclerosis. The results of the online DBT-Mindfulness intervention will be compared to an active control group (psychoeducational intervention) to see if they improve her emotion dysregulation and decentering, and consequently, this benefits also improve symptoms like anxiety, depression, distress, fatigue and quality of life in people with MS.
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic...
Interstitial Lung DiseaseThis is a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20.
Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
Multiple SclerosisThe purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis.
Best Available Therapy Versus Autologous Hematopoetic Stem Cell Transplant for Multiple Sclerosis...
Relapsing Multiple SclerosisRelapsing Remitting Multiple Sclerosis1 moreThis is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
Study of Safety and of the Mechanism of BLZ945 in ALS Patients
Amyotrophic Lateral SclerosisIt is an open label study to evaluate safety, tolerability and brain microglia response in participants with ALS following multiple doses of BLZ945.