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Muscular Atrophy, Spinal clinical trials

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NCT ID: NCT03808233 Completed - Clinical trials for Spinal Muscular Atrophy

Reliability and Validity of the ACTIVE-mini for Quantifying Movement in Infants With Spinal Muscular Atrophy

Start date: November 5, 2016
Phase:
Study type: Observational

The purpose of this study is to investigate the measurement properties of the Ability Captured Through Interactive Video Evaluation-mini (ACTIVE-mini) for quantifying movement in infants with Spinal Muscular Atrophy (SMA). Specifically, I will investigate within-day and between-day test-retest reliability and calculate the minimal detectable change of the ACTIVE-mini. Additionally, I will determine the concurrent validity of the ACTIVE-mini with The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease (CHOP INTEND) and the construct validity of the ACTIVE-mini in infants with SMA using a known group methodology.

NCT ID: NCT03781479 Completed - Clinical trials for Muscular Atrophy, Spinal

Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients

Start date: January 21, 2019
Phase: Phase 2
Study type: Interventional

A two-period, two-treatment, crossover study to evaluate the safety, tolerability and efficacy of amifampridine phosphate in ambulatory patients diagnosed with spinal muscular atrophy (SMA) Type 3.

NCT ID: NCT03706391 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Study of ALS Reversals 4: LifeTime Exposures

StARLiTE
Start date: September 26, 2018
Phase:
Study type: Observational [Patient Registry]

Hypothesis: There exists patients who have met ALS or PMA diagnostic criteria and subsequently experienced robust and sustained improvement, i.e. a "reversal." Thirty-eight of these patients were identified in the prior Duke University study, Documentation of Known ALS Reversals (St.A.R. Protocol 1, Duke IRB Pro00076395). The investigators hypothesize these patients have had different environmental exposures than patients with typically progressive ALS. Identification of specific environmental influences may point to exposures which are protective or exposure that lead to the development of a rare and novel reversible ALS-like disease. Objective: This study seeks to identify environmental exposures associated with ALS reversals.

NCT ID: NCT03554343 Completed - Clinical trials for Spinal Muscular Atrophy

Sun May Arise on SMA : Newborn Screening of Spinal Muscular Atrophy in Belgium

Start date: March 5, 2018
Phase:
Study type: Observational

Medico-economic study of Newborn screening of Spinal Muscular Atrophy

NCT ID: NCT03505099 Completed - Clinical trials for Spinal Muscular Atrophy

Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2

SPR1NT
Start date: April 2, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2

NCT ID: NCT03464903 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Study of ALS Reversals 2: Genetic Analyses

StAR2
Start date: June 22, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to try to understand why reversals of amyotrophic lateral sclerosis (ALS) and primary muscular atrophy (PMA) take place. The study will enroll patients with ALS or PMA reversals to give saliva samples in order to determine if the ALS or PMA reversal is because of certain changes in the genetic code.

NCT ID: NCT03461289 Completed - SMA Clinical Trials

Single-Dose Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1

STRIVE-EU
Start date: August 16, 2018
Phase: Phase 3
Study type: Interventional

Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet enrollment criteria and are genetically defined by a biallelic pathogenic mutation of the survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene (SMN2). Up to 30 patients < 6 months (< 180 days) of age at the time of gene replacement therapy (Day 1) will be enrolled.

NCT ID: NCT03395795 Completed - Clinical trials for Infantile Spinal Muscular Atrophy

Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II

NAVASI
Start date: February 13, 2018
Phase: N/A
Study type: Interventional

The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient. To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.

NCT ID: NCT03339830 Completed - Clinical trials for Spinal Muscular Atrophy

European Registry of Patients With Infantile-onset Spinal Muscular Atrophy

Start date: October 10, 2017
Phase:
Study type: Observational [Patient Registry]

IO-SMA-Registry is a prospective, longitudinal and observational study which objective is to collect prospectively information on longevity, psychomotor development and respiratory function of patients with infantile-onset spinal muscular atrophy.

NCT ID: NCT03306277 Completed - Gene Therapy Clinical Trials

Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1

STR1VE
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

Phase 3 pivotal US trial studying open-label intravenous administration of onasemnogene abeparvovec-xioi in spinal muscular atrophy (SMA) Type 1 participants.