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Nusinersen for Spinal Muscular Atrophy (NURTURE Trial)
NURTURE Trial Summary
This trial is testing if a certain medication can help prevent or delay the need for respiratory intervention or death in infants with a genetic diagnosis of Spinal Muscular Dystrophy.
NURTURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNURTURE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 126 Patients • NCT02292537NURTURE Trial Design
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Who is running the clinical trial?
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- I have not had gene therapy, ASO treatment, or cell transplantation for SMA.I have a confirmed genetic form of SMA.I show signs that my doctor thinks could be SMA.You have important problems with your blood or other body chemicals.My genetic test shows I have 2 or 3 copies of the SMN2 gene.Your ulnar nerve's electrical activity is normal at the start of the study.I am 6 weeks old or younger.You meet other requirements specific to the study.Your oxygen levels are too low, even when you are resting or sleeping, and you don't use any extra oxygen or breathing support.You are carrying a baby for at least 37 weeks but no more than 42 weeks for one baby, and at least 34 weeks but no more than 42 weeks for two babies.
- Group 1: Nusinersen
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has recruitment for this investigation commenced?
"Unfortunately, according to clinicaltrials.gov the trial is not enrolling patients at this time; however, it was initially posted on May 20th 2015 and last updated November 11 2021. Despite this setback, there are over two hundred other trials that are currently recruiting participants."
What is the participant quota for this experiment?
"This research project is no longer enrolling, as the clinical trial was first posted on May 20th 2015 and last revised on November 11th 2021. For those searching for other studies, there are 205 atrophic trials presently recruiting participants, in addition to 7 medical investigations seeking patients receiving Nusinersen treatments."
How many medical facilities are actively conducting this trial?
"The current medical trial is enrolling participants at 8 distinct sites, located in Boston, New york and Los Angeles as well other locations. To reduce travel strain, one should consider the site closest to them if they wish to partake."
Have any other trials been conducted utilizing Nusinersen?
"Nusinersen was initially studied in 2015 at Research Site and currently, there are 9 completed trials. There is also a notable number of ongoing medical studies that are being conducted from multiple sites within Boston, Massachusetts."
What impact has Nusinersen had on patient safety metrics?
"With a score of 2, there has been some evidence collected on Nusinersen's safety profile, although the efficacy of this intervention remains unproven."
Is this a pioneering endeavor with no precedent?
"Since its inception in 2015, Nusinersen has been rigorously explored. Biogen sponsored the initial trial involving 25 patients and it was shortly thereafter that Phase 2 clinical approval was granted. At present, 7 live trials are located across 70 cities and 31 countries."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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