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Sclerosis clinical trials

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NCT ID: NCT05119569 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

FENopta
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo.

NCT ID: NCT05084638 Active, not recruiting - Clinical trials for Relapse Remitting Multiple Sclerosis

Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

AGNOS
Start date: January 25, 2022
Phase: Phase 4
Study type: Interventional

This study will evaluate the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study will also assess changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.

NCT ID: NCT05081700 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Systems Approach to Understanding Disease Processes in Multiple Sclerosis

Start date: May 11, 2020
Phase:
Study type: Observational

This pilot study will establish a proof of concept for using a systems biology approach to characterize the dynamics of MS disease processes. The primary objective of the study is to identify multi-omic (genetic, proteomic, biochemical and/or microbial) factors that correlate with clinical and subclinical MS disease activity. Identification of such biomarkers could have an immediate clinical utility in identification of MS patients prone to more aggressive disease earlier in their disease course, thus affording the opportunity to better individualize therapy. In addition, insights from better understanding of the complex interplay of various systems biology factors should improve our understanding of MS in general. The study will recruit 14 patients with relapsing MS who are initiating treatment with ocrelizumab, and follow them for 30 months.

NCT ID: NCT05054140 Active, not recruiting - Multiple Sclerosis Clinical Trials

Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

CALLIPER
Start date: September 30, 2021
Phase: Phase 2
Study type: Interventional

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER

NCT ID: NCT05021536 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

Phoenix
Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS

NCT ID: NCT05012241 Active, not recruiting - Motor Activity Clinical Trials

The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis

Start date: September 1, 2021
Phase:
Study type: Observational

The main aim of the project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test administered according to the new Czech extended version manual in patients with multiple sclerosis.

NCT ID: NCT05006352 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

Start date: August 11, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL343 in participants with amyotrophic lateral sclerosis (ALS)

NCT ID: NCT04993755 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD

Start date: October 1, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2a study to assess the the safety and tolerability of TPN-101 in patients with Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated with Hexanucleotide Repeat Expansion in the C9orf72 gene (C9ORF72 ALS/FTD).

NCT ID: NCT04993274 Active, not recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Sensitivity of Motor Assessment in MS - a Prospective Cohort Study

MOTOSENS
Start date: February 20, 2019
Phase:
Study type: Observational

The study explores the application of marker-less motion analysis (visual-perceptive computing, VPC) using a consumer grade infrared and video camera (Microsoft Kinect) for clinical assessment in MS. It includes as the primary outcomes a short assessment battery of simple motor tasks (PASS-MS) that can be performed in front of the sensor after standard oral instructions given by the operator. For each task, the sensor data are transformed into a set of kinematic parameters that may be used as motor outcome reflecting specific neurological dysfunction. For validation against both clinical and patient-reported outcomes as well as MRI findings, we here prospectively investigate a large cohort of patients with multiple sclerosis. This will allow to determine the usefulness of the various kinematic parameters generated and to define a reduced set of the most meaningful parameters for potential use in future MS trials. Data on repeatability and benchmarks for clinically relevant change are essential to interpret test results and, more importantly, changes thereof. Further, this prospective study will yield estimates of progression rates that are required for planning future studies using this motion analysis tool and assessment battery as an outcome. The study is designed to obtain benchmarks for sensitivity and clinical responsiveness. Primary analysis aims to answer the question: Does the SMSW - Maximum Speed worsen with disease progression established as confirmed disability progression based on EDSS after 24 months (defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS > 5.5)?

NCT ID: NCT04988880 Active, not recruiting - Multiple Sclerosis Clinical Trials

Territorial Implementation and Evaluation of a Multiple Sclerosis Expert Patient Program

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Introduction: Multiple sclerosis (MS) affects about 50,000 people in Spain, so it is essential to implement health interventions that meet their needs and demands. Expert patient programs facilitate health-related empowerment through peer learning. From a study of focus groups that identified the characteristics and contents of an expert patient program for MS and the ongoing pilot tests, the need for implementation in the different reference units of Catalonia is established. Hypothesis: The territorial implementation in Catalonia of a Catalonia® Expert Patient Program for people with MS (PPEC-EM) based on peer learning will improve the quality of life, knowledge and self-management related to the health process of the participants. Objective: To deploy and evaluate the territorial implementation of a PPEC-EM based on peer learning regarding the quality of life, knowledge and self-management related to the health process of the participants. Methodology: Pre-post intervention multicenter clinical study. This study will begin after the approval of the respective Ethics Committees. The deployment will consist of 12 groups of patients (2 per unit): 6 groups with people with recurrent MS and 6 groups with people with progressive MS. A patient with MS previously trained by a team of health professionals will lead 9 educational group sessions (1 weekly session for 9 weeks) with 12 people with the same disease in order to improve the impact and self-management according to the health process. The main variable is the improvement of the quality of life and the secondary ones are the emotional impact, activation of the person, knowledge on the MS, fatigue, habits and lifestyles, use of the sanitary services and program-related experience of participants. All variables will be measured before and after the intervention and after 6 and 12 months. A pre-post comparability analysis will be developed in relation to the variables studied.