ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)

ClinicalTrials.gov ID: NCT07448610

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Official title

Onasemnogene Abeparvovec: ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary purpose is to address critical evidence in the treatment landscape for Spinal Muscular Atrophy (SMA), specifically focusing on the intrathecal formulation of onasemnogene abeparvovec-brve (ITVISMA®). U.S. Pragmatic Multicenter Study (STREAM).

Study identification

NCT ID: NCT07448610
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 4
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 36 participants

Conditions and interventions

Conditions

Spinal Muscular Atrophy

Interventions

Onasemnogene Abeparvovec-brve Drug

Drug

Eligibility (public fields only)

Age range: 2 Years to 100 Years
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 27, 2026 (Actual)
Primary completion: May 3, 2032 (Estimated)
Completion: Jun 30, 2032 (Estimated)
Last update posted: Oct 29, 2026

2026 – 2032

United States locations

U.S. sites: 6
U.S. states: 6
U.S. cities: 6

Facility	City	State	ZIP	Site status
Arkansas Children's Hospital	Little Rock	Arkansas	208833	Recruiting
Stanford Hospital	Stanford	California	94305-5235	Recruiting
Boston Childrens Hospital	Boston	Massachusetts	02215	Recruiting
Columbia University Medical Center	New York	New York	10032	Recruiting
Ohio State University Medical Center	Columbus	Ohio	43210	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	209277	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07448610, 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 Oct 29, 2026 · Synced Nov 15, 2026