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Muscular Atrophy, Spinal clinical trials

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NCT ID: NCT00774423 Completed - SMA Clinical Trials

Study to Evaluate the Efficacy of Riluzole in Children and Young Adults With Spinal Muscular Atrophy (SMA)

ASIRI
Start date: January 2006
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicentric, randomized, double-blind study versus placebo, with two parallel groups treated to evaluate the efficacy and the tolerance of Riluzole in children and young adults (6 to 20 years of age) with SMA. (Type II and Type III).

NCT ID: NCT00756821 Completed - Clinical trials for Spinal Muscular Atrophy

A Pilot Study of Biomarkers for Spinal Muscular Atrophy

BforSMA
Start date: October 2008
Phase: N/A
Study type: Observational

The goal of this pilot study is to identify a marker or panel of markers in the blood or urine from a wide range of Spinal Muscular Atrophy (SMA) patients that segregates with measures of clinical severity. From this identification of candidate biomarkers, it is hoped that further investigations, both longitudinal natural history and clinical efficacy studies, will verify a biomarker with the sensitivity and specificity that will allow its eventual use as a validated pharmacodynamic marker or surrogate endpoint. In addition, this effort may elucidate biological pathways that may be potential therapeutic targets.

NCT ID: NCT00661453 Completed - Clinical trials for Spinal Muscular Atrophy Type I

CARNIVAL Type I: Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy (SMA) Type I

Start date: April 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center trial to test safety and evaluate early treatment intervention with valproic acid and carnitine in moderating SMA symptoms of Type I infants.

NCT ID: NCT00568802 Completed - Clinical trials for Muscular Atrophy, Spinal

A Pilot Therapeutic Trial Using Hydroxyurea in Type II and Type III Spinal Muscular Atrophy Patients

Start date: January 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in children with Types II and III Spinal Muscular Atrophy; to identify reliable outcome measures for HU treatment in Types II and III SMA; and to detect the clinical efficacy of HU treatment in children with Types II and III SMA.

NCT ID: NCT00568698 Completed - Clinical trials for Muscular Atrophy, Spinal

A Pilot Therapeutic Trial Using Hydroxyurea in Type I Spinal Muscular Atrophy Patients

Start date: January 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in children with Type I Spinal Muscular Atrophy; to identify reliable outcome measures for HU treatment in Type I SMA; and to detect the clinical efficacy of HU treatment in children with Type I SMA.

NCT ID: NCT00533221 Completed - Clinical trials for Muscular Atrophy, Spinal

Pilot Study of Growth Hormon to Treat SMA Typ II and III

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Growth hormon can increase strength in spinal muscular atrophy type II and III.

NCT ID: NCT00528268 Completed - Clinical trials for Spinal Muscular Atrophy

Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy

STOPSMA
Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants. A variety of outcome measures will be performed at each study visit to follow the course of the disease. Total duration of the study for type I infants will be 18 months, for type II infants, 24 months.

NCT ID: NCT00485511 Completed - Clinical trials for Spinal Muscular Atrophy

A Trial of Hydroxyurea in Spinal Muscular Atrophy

Start date: June 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Spinal muscular atrophy (SMA) is an autosomal recessive disorder in humans which results in the loss of motor neurons. It is caused by reduced levels of the survival motor neuron (SMN) protein as a result of loss or mutation of the SMN1 gene. SMN protein is encoded by two genes, SMN1 and SMN2, which essentially differ by an single nucleotide in exon 7. As a result, the majority of the transcript from SMN2 lacks exon 7. According to clinical severity, SMA was classified to three types, including type I, type II, and type III. Drugs capable of modifying the transcription pattern of SMN2 to increase the full-length of SMN mRNA expression and the amount of SMN protein may have therapeutic effects for SMA patients. In order to test this hypothesis, we used EBV-transformed lymphoblastoid cell lines derived from the different types of SMA patients to screen the effect of various drugs on SMN2 gene expression. Hydroxyurea (HU) was found to be effective among the drugs we tested. HU is an effective therapeutic agent for patients with thalassemia and sickle cell disease which the toxicity is minimal and is well-tolerated and safely used in children. We had undergone a small-scaled 33 SMA patients randomized pilot trial (HU treatment for 8 weeks and then follow up drug-free 8 weeks) to evaluate the effect of HU in SMA patients and we got a promising preliminary data. We found that HU could significantly increase in the manual muscle testing scores at 4 weeks, and full-length SMN mRNA level in the 30mg/kg/day subgroup at 8 weeks relative to baseline, and it is safe under the dose 30mg/kg/day. In this study, we plan to enroll 60 type II and III SMA patients and conduct a single-center, randomized, double-blind, placebo-controlled, prospective trial of two-year duration to evaluate the efficacy and safety of HU.The primary end points are the changes in full-length SMN expression, SMN protein, motor function and lung function in SMA patients. We also design a safety monitoring system to investigate the adverse effects and to assure the patients' safety. We hope we can find and prove the efficacy and safety of HU in SMA patients and set up a evaluating model for multi-center trials in the future.

NCT ID: NCT00481013 Completed - Clinical trials for Spinal Muscular Atrophy

Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy

VALIANTSMA
Start date: July 2007
Phase: Phase 2
Study type: Interventional

The primary objective of this proposal is to determine whether oral VPA is effective in treating SMA in adult patients.

NCT ID: NCT00466349 Completed - Clinical trials for Muscular Atrophy, Spinal

International SMA Patient Registry

Start date: May 1986
Phase:
Study type: Observational [Patient Registry]

This is a registry of individuals affected by Spinal Muscular Atrophy (SMA) and/or family members of individuals affected by SMA. The purpose of the registry is to allow researchers studying the biological basis of SMA and potential therapies in SMA access to individuals interested in participating in research and/or experimental therapies. The International SMA Patient Registry is supported by CureSMA.