New implant could change how SMA patients get their medicine
NCT ID NCT06555419
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how the body handles the drug nusinersen when given through a new implantable device called ThecaFlex DRx™, compared to the usual method of a lumbar puncture (spinal tap). About 58 people with spinal muscular atrophy (SMA) who are already in another study (PIERRE) will receive one dose by lumbar puncture and one dose through the device. Researchers will measure drug levels in the blood to see if the device works as well as the standard procedure.
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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITINGChicago, Illinois, 60611-2605, United States
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Children's Hospital of Orange County
RECRUITINGOrange, California, 92868, United States
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's Hospital of the King's Daughters_Norfolk
RECRUITINGNorfolk, Virginia, 23507, United States
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
WITHDRAWNRoma, 168, Italy
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Fondazione Serena Onlus - Centro Clinico Nemo_Milano
WITHDRAWNMilan, 20162, Italy
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Helen DeVos Children's Hospita
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Hospital Universitari i Politecnic La Fe_Valencia
RECRUITINGValencia, 46026, Spain
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Hospital Universitario La Paz
RECRUITINGMadrid, 28046, Spain
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Hôpital Raymond Poincaré
RECRUITINGGarches, Hauts De Seine, 92380, France
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Instytut Centrum Zdrowia Matki Polki
NOT_YET_RECRUITINGLodz, 93-338, Poland
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Milton S. Hershey Medical Center | Pennsylvania State University_Hershey
RECRUITINGHershey, Pennsylvania, 17033, United States
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Royal Hallamshire Hospital Neurology Department
RECRUITINGSheffield, South Yorkshire, S102JF, United Kingdom
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Stacey Hall Developmental Pediatrics
RECRUITINGCharlottesville, Virginia, 22903, United States
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Stanford University Medical Center | Department of Neurology_Palo Alto
RECRUITINGPalo Alto, California, 94304, United States
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Szpital Specjalistyczny im. L.Rydygiera w Krakowie
NOT_YET_RECRUITINGKrakow, 31-826, Poland
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Texas Childrens Hospital Houston
RECRUITINGHouston, Texas, 77030, United States
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Universitaetsklinikum Essen
RECRUITINGEssen, 45147, Germany
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