New implant could change how SMA patients get their medicine

NCT ID NCT06555419

Recruiting now Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

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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Conditions

The condition(s) this trial relates to.

spinal muscular atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MUSCULAR ATROPHY, SPINAL

Contacts and locations

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING

Chicago, Illinois, 60611-2605, United States
Boston Children's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Children's Hospital of Orange County
RECRUITING

Orange, California, 92868, United States
Children's Hospital of Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of the King's Daughters_Norfolk
RECRUITING

Norfolk, Virginia, 23507, United States
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
WITHDRAWN

Roma, 168, Italy
Fondazione Serena Onlus - Centro Clinico Nemo_Milano
WITHDRAWN

Milan, 20162, Italy
Helen DeVos Children's Hospita
RECRUITING

Grand Rapids, Michigan, 49503, United States
Hospital Universitari i Politecnic La Fe_Valencia
RECRUITING

Valencia, 46026, Spain
Hospital Universitario La Paz
RECRUITING

Madrid, 28046, Spain
Hôpital Raymond Poincaré
RECRUITING

Garches, Hauts De Seine, 92380, France
Instytut Centrum Zdrowia Matki Polki
NOT_YET_RECRUITING

Lodz, 93-338, Poland
Milton S. Hershey Medical Center | Pennsylvania State University_Hershey
RECRUITING

Hershey, Pennsylvania, 17033, United States
Royal Hallamshire Hospital Neurology Department
RECRUITING

Sheffield, South Yorkshire, S102JF, United Kingdom
Stacey Hall Developmental Pediatrics
RECRUITING

Charlottesville, Virginia, 22903, United States
Stanford University Medical Center | Department of Neurology_Palo Alto
RECRUITING

Palo Alto, California, 94304, United States
Szpital Specjalistyczny im. L.Rydygiera w Krakowie
NOT_YET_RECRUITING

Krakow, 31-826, Poland
Texas Childrens Hospital Houston
RECRUITING

Houston, Texas, 77030, United States
Universitaetsklinikum Essen
RECRUITING

Essen, 45147, Germany

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