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Muscular Atrophy, Spinal clinical trials

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NCT ID: NCT05335876 Recruiting - Clinical trials for Spinal Muscular Atrophy (SMA)

Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

SPECTRUM
Start date: December 19, 2022
Phase: Phase 3
Study type: Interventional

This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 15 years from the date of OAV101 administration in the previous clinical trial.

NCT ID: NCT05272969 Recruiting - Clinical trials for Pompe Disease (Late-onset)

Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe Disease

Start date: March 31, 2022
Phase:
Study type: Observational

The primary aim of this nationwide, explorative, cross-sectional study in Germany is to characterize the prevalence, severity and quality of musculoskeletal pain in adult patients with late-onset Pompe disease (LOPD). The secondary objectives are to evaluate whether muscle pain is associated with muscle function, to assess whether muscle pain is associated with alterations of muscle tissue, and whether vitamin D metabolism and polymorphisms of ACE and ACTN3 genes may contribute to an increased level of perceived musculoskeletal pain. In a second step, exome sequencing of genes associated with musculoskeletal pain will be analyzed. Results of LOPD patients will be compared to patients with neuromuscular disorders with a similar distribution of muscle weakness and/or musculoskeletal pain.

NCT ID: NCT05232929 Recruiting - Clinical trials for Spinal Muscular Atrophy

Long-Term Follow-Up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)

WeSMA
Start date: June 14, 2022
Phase: Phase 4
Study type: Interventional

A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S. Package Insert (USPI) in adult and pediatric participants with spinal muscular atrophy (SMA). In this study, participants will be followed for up to 5 years from enrollment or until withdrawal of consent, loss to follow-up, or death. Participants who discontinue risdiplam may still remain in the study, if they agree to continue participating in the follow-up assessments.

NCT ID: NCT05219487 Recruiting - Clinical trials for Spinal Muscular Atrophy

Investigating NMJ Defects in SMA Following Central and Peripheral SMN Restoration

Start date: October 13, 2021
Phase:
Study type: Observational

This is an observational study to investigate the improvement of NMJ defects in adult patients with SMA following treatment with Risdiplam. Eligible patients will have received treatment with daily oral Risdiplam after receiving approval through their commercial insurance or drug assistance program. All subjects will be evaluated at one visit. Eligible subjects must have been receiving risdiplam for at least 12 months.

NCT ID: NCT05204017 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Comprehensive Analysis Platform To Understand, Remedy and Eliminate ALS

CAPTURE ALS
Start date: September 12, 2021
Phase:
Study type: Observational

CAPTURE ALS is a long-term data and biorepository platform that will facilitate future ALS research. CAPTURE ALS will provide the standardized systems and tools necessary to collect, store, and analyze vast amounts of multimodal information about ALS. These multimodal datasets and biosamples will be made available for use by researchers or industry across Canada and around the world in accordance with the CAPTURE ALS Data Sharing Policy to advance research on ALS.

NCT ID: NCT05187260 Recruiting - Clinical trials for Spinal Muscular Atrophy

Antisense Oligonucleotide for Spinal Muscular Atrophy

Start date: January 1, 2022
Phase:
Study type: Observational

This is a longitudinal, multiple-center, observational study of patients genetically confirmed chromosome 5q SMA to monitor the efficacy, safety, tolerability of SPINRAZA® (nusinersen) for up to 24 months.

NCT ID: NCT05115110 Recruiting - Clinical trials for Spinal Muscular Atrophy (SMA)

A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy

MANATEE
Start date: June 2, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Risdiplam works by helping the body produce more survival motor neuron (SMN) protein throughout the body. This means fewer motor neurons - nerve cells that pass impulses from nerves to muscles to cause movement - are lost, which may improve how well muscles work in people with SMA. RO7204239 is an investigational anti-myostatin antibody that is designed to target myostatin. Myostatin plays an important role in the regulation of skeletal muscle size by controlling growth. Inhibiting myostatin may help muscles grow in size and strength. RO7204239 in combination with risdiplam, which is designed to increase the amount of SMN protein throughout the body, has the potential to further improve motor function and clinical outcomes for people living with SMA. This trial will study the safety and efficacy of RO7204239 in combination with risdiplam in patients with spinal muscular atrophy (SMA). The trial has two parts; Part 1 is the dose-finding part in SMA patients that are either ambulant (aged 2-10 years) or non-ambulant (aged 5-10 years) within separate cohorts, and Part 2 is the pivotal part in SMA patients aged 2-25 years that are ambulant.

NCT ID: NCT05067790 Recruiting - Clinical trials for Spinal Muscular Atrophy

A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Previously Treated With Risdiplam

ASCEND
Start date: January 21, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate motor function following treatment with HD nusinersen in participants with spinal muscular atrophy (SMA) previously treated with risdiplam. The secondary objective of this study is to evaluate the safety and tolerability of HD nusinersen in participants with SMA previously treated with risdiplam.

NCT ID: NCT05042921 Recruiting - Clinical trials for Muscular Atrophy, Spinal

Pediatric Spinal Muscular Atrophy (SMA) China Registry

Start date: November 18, 2021
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) treatments among pediatric Chinese participants with spinal muscular atrophy linked to chromosome 5q (5q-SMA).

NCT ID: NCT04875416 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Phenotype, Genotype and Biomarkers 2

PGB2
Start date: January 8, 2021
Phase:
Study type: Observational

The purpose of this study is to learn more about amyotrophic lateral sclerosis (ALS) and other related neurodegenerative diseases, including frontotemporal dementia (FTD), primary lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy (PMA) and multisystem proteinopathy (MSP). More precisely, the investigator wants to identify the links that exist between the disease phenotype (phenotype refers to observable signs and symptoms) and the disease genotype (genotype refers to your genetic information). The investigator also wants to identify biomarkers of ALS and related diseases.