A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).
Public ClinicalTrials.gov record NCT02462759. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-blind, Sham-procedure Controlled Study to Assess the Safety and Tolerability and Explore the Efficacy of ISIS 396443 (BIIB058) Administered Intrathecally in Subjects With Spinal Muscular Atrophy Who Are Not Eligible to Participate in the Clinical Studies ISIS 396443-CS3B or ISIS 396443-CS4
Study identification
- NCT ID
- NCT02462759
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Biogen
- Industry
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Interventions
- Nusinersen Drug
- Sham Procedure Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 2015
- Primary completion
- Sep 23, 2018
- Completion
- Sep 23, 2018
- Last update posted
- Feb 16, 2021
2015 – 2018
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095-8344 | — |
| Connecticut Childrens Medical | Hartford | Connecticut | 06106 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | — |
| Seattle Children's Research Institute | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02462759, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 16, 2021 · Synced Jun 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02462759 live on ClinicalTrials.gov.