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Muscular Atrophy, Spinal clinical trials

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NCT ID: NCT01780246 Completed - Clinical trials for Spinal Muscular Atrophy

An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1 (NCT01494701)

Start date: January 31, 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to examine the safety and tolerability of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA) who previously participated in ISIS 396443-CS1 (NCT02865109). The secondary objective was to examine the plasma pharmacokinetics of a single dose of ISIS 396443 administered intrathecally to participants with SMA who previously participated in ISIS 396443-CS1.

NCT ID: NCT01754441 Completed - Clinical trials for Spinal Muscular Atrophy

Mechanisms of Cell Death in Spinal Muscular Atrophy

Start date: May 2008
Phase:
Study type: Observational

Spinal muscular atrophy is a genetically based disease that affects motor neurons in the spinal cord and leads to muscle wasting and weakness. The gene found to be responsible for the underlying disease is called the SMN or survival motor neuron gene. Individuals with SMA are either missing a copy of the gene or have a mutation in the gene. Although the gene has been identified, how it actually causes the motor neurons to die and leads to muscle wasting and weakness is not completely understood. The investigators have found that skin cells from children with SMA tend to be more susceptible to cell death when exposed to cell death inducing agents. In this protocol, The investigators wish to study the mechanisms by which these cells die when exposed to these agents and how this may be related to the gene defect and the disease.

NCT ID: NCT01736553 Completed - Clinical trials for Spinal Muscular Atrophy (SMA)

Spinal Muscular Atrophy (SMA) Biomarkers Study in the Immediate Postnatal Period of Development

Start date: December 2012
Phase:
Study type: Observational

Spinal muscular atrophy (SMA) is the leading genetic cause of death of infants. Strong preclinical evidence suggests that effective therapy must be delivered as early as possible to prevent progression of the disease. The primary study objective will be to identify prognostic and surrogate biomarkers of disease progression that will facilitate the execution of therapeutic SMA clinical trials in infants.

NCT ID: NCT01703988 Completed - Clinical trials for Spinal Muscular Atrophy

An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy

Start date: October 31, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test the safety, tolerability, and pharmacokinetics of escalating doses of nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over the duration of the trial, in participants with spinal muscular atrophy (SMA). Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort of approximately 8 participants, where all participants will receive active drug.

NCT ID: NCT01645787 Completed - Clinical trials for Spinal Muscular Atrophy

Short and Long Term Treatment With 4-AP in Ambulatory SMA Patients

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess whether 4-AP (Dalfampridine-ER, Ampyra) improves walking ability and endurance in adult patients with Spinal muscular atrophy (SMA) Type 3 compared to placebo and whether the duration of treatment affects outcome.

NCT ID: NCT01611610 Completed - Clinical trials for Spinal Muscular Atrophy

Clinical Assessment of Spinal Muscular Atrophy Type II and III (SMA Europe)

Start date: May 2011
Phase: N/A
Study type: Interventional

The aim of this project is to establish a network of clinical teams including the major neuromuscular centers in Europe. We plan to work together to find the best common outcome measures for the following multicenter therapeutic trials.

NCT ID: NCT01522079 Completed - Clinical trials for Spinal Muscular Atrophy

Spinal Muscular Atrophy and Cardiac Autonomic Function

Start date: January 2011
Phase: N/A
Study type: Interventional

Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear. Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic function in patients with spinal muscular atrophy types II and III. Methods: Patients with spinal muscle atrophy type II and III will be recruited. Electrocardiogram signals will be recorded for analyses of heart rate variability during air stacking in supine and sitting position.

NCT ID: NCT01494701 Completed - Clinical trials for Spinal Muscular Atrophy

An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)

SMNRx
Start date: November 30, 2011
Phase: Phase 1
Study type: Interventional

This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).

NCT ID: NCT01422200 Completed - Clinical trials for Duchenne Muscular Dystrophy

Flu Vaccine Study in Neuromuscular Patients 2011

Start date: August 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare the immune response of two different injection methods (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among patients with neuromuscular conditions who have significant muscle degeneration. This research study hypothesizes that the subcutaneous route of vaccine administration, as compared to the intramuscular route, may confer at least comparable, or possibly better, immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive Care Center will be recruited to participate in this study lasting approximately one to two months with two clinic visits and one follow-up telephone call. Immunogenicity will be assessed by comparing hemagglutination inhibition (HI) antibody titers obtained pre- and post-vaccination.

NCT ID: NCT01302600 Completed - Clinical trials for Spinal Muscular Atrophy Type II

Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients.

Start date: November 2010
Phase: Phase 2
Study type: Interventional

Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years