A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies
Completed · Phase 3
Conditions studied: Spinal Muscular Atrophy
In brief
The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.
Key facts
- Study ID
- NCT02594124
- Run by
- Biogen
- People needed
- 292
- Starts
- 2015-11-04
- Expected to finish
- 2023-08-21
- Last updated by the study team
- 2024-10-22
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States
- Stanford University School of Medicine — Palo Alto, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- Nemours Children's Clinic — Orlando, Florida, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — New York, Illinois, United States
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Columbia University Medical Center — New York, New York, United States
- Duke University School of Medicine — Durham, North Carolina, United States
- Duke University School of Medicine — Miyagi, North Carolina, United States
- Oregon Health Sciences University — Durham, Oregon, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Children's Medical Center — Dallas, Texas, United States
- University of Utah — Obu, Aichi, Utah, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Sydney Children's Hospital Clinical Research Centre — Sydney, New South Wales, Australia
- Royal Children's Hospital — Parkville, Victoria, Australia
- Universitair Kinderziekenhuis Koningin Fabiola — Brussels, Belgium
- BC Children's Hospital / UBC — Vancouver, British Columbia, Canada
- Children's Health Research Institute — Brussel, Ontario, Canada
- McGill University Health Centre — Montreal, Quebec, Canada
- Armand Trousseau Hospital, I-Motion — Paris, Paris 9, France
Full record on ClinicalTrials.gov
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