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NCT05335876 · ClinicalTrials.gov registry record · Phase 3

Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

A Phase 3 study of Spinal Muscular Atrophy (SMA), sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
175
Enrollment target
20
Study locations

NCT05335876 is a Phase 3 study of Spinal Muscular Atrophy (SMA) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 175 participants, below the 248-participant average among 5 other Spinal Muscular Atrophy (SMA) trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT05335876, a Phase 3 study of Spinal Muscular Atrophy (SMA), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
175 participants
Enrollment target
20
Study locations

Study Summary

This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.

Conditions Studied

Spinal Muscular Atrophy (SMA)

Interventions

  • BIOLOGICAL onasemnogene abeparvovec

Study Locations (20)

Other

  • Novartis Investigative Site - Leuven
  • Novartis Investigative Site - Beijing
  • Novartis Investigative Site - Beijing
  • Novartis Investigative Site - Beijing
  • Novartis Investigative Site - Copenhagen
  • Novartis Investigative Site - Bron
  • Novartis Investigative Site - Garches
  • Novartis Investigative Site - Strasbourg
  • Novartis Investigative Site - Toulouse

Virginia

  • Child Hosp Of The Kings Daughters - Norfolk

New South Wales

  • Novartis Investigative Site - Sydney

Paraná

  • Novartis Investigative Site - Curitiba

São Paulo

  • Novartis Investigative Site - São Paulo

Quebec

  • Novartis Investigative Site - Montreal

Chongqing Municipality

  • Novartis Investigative Site - Chongqing

Guangdong

  • Novartis Investigative Site - Guangzhou

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2022-12-19
Est. Completion 2031-02-27
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05335876

The ClinicalTrials.gov registry entry for NCT05335876 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 248-participant average among 5 other Spinal Muscular Atrophy (SMA) trials with a reported enrollment target (29% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Spinal Muscular Atrophy (SMA) appearing as the primary indexed condition, and to 1 intervention - of which onasemnogene abeparvovec is the first listed.

NCT05335876 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Virginia, New South Wales.

Frequently Asked Questions

What is clinical trial NCT05335876 about?

NCT05335876 is a clinical study titled "Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials". This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.

What is the current status of trial NCT05335876?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2022-12-19. Estimated completion is 2031-02-27.

What conditions does trial NCT05335876 study?

This clinical trial studies the following conditions: Spinal Muscular Atrophy (SMA).

What interventions are being tested in trial NCT05335876?

The interventions under investigation include: onasemnogene abeparvovec (BIOLOGICAL).

Who is sponsoring clinical trial NCT05335876?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05335876 being conducted?

This trial has 20 study locations across Virginia, New South Wales, Paraná, São Paulo, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.