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Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection | Clinical Trials | Clareo Health

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Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection

A Multicenter, Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection When Used in Routine Medical Practice in China

NCT04419233•Biogen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in China.The secondary objectives are to collect data on the efficacy and the pharmacokinetics of nusinersen sodium injection in the post-marketing setting in China.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability of the participant or his/her legally authorized representative (e.g., parent or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
•The decision to newly prescribe nusinersen sodium injection according to the local marketing authorization, including documentation of 5q SMA diagnosis, has been made by the Investigator and agreed to by the participant (or legally authorized representative)

Exclusion Criteria

•Hypersensitivity to the active substance or any of the excipients of nusinersen sodium injection.
•Current or past administration of nusinersen sodium injection, in either a commercial or a clinical study setting.
•Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment.

Locations (9)

Research Site

Xicheng, Beijing Municipality, China

Research Site

Fuzhou, Fujian, China

Research Site

Guangzhou, Guangdong, China

Research Site

Suzhou, Jiangsu, China

Research Site

Changchun, Jilin, China

Research Site

Minhang, Shanghai Municipality, China

Research Site

Chengdu, Sichuan, China

Research Site

Beijing, Xicheng, China

Research Site

Hangzhou, Zhejiang, China

Key Dates

Start Date

November 18, 2020

Primary Completion Date

November 21, 2023

Completion Date

November 21, 2023

Last Updated

December 7, 2023

Enrollment

ACTUAL participants

Conditions

Muscular Atrophy, Spinal

Interventions

Nusinersen Sodium Injection

DRUG

A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy

NCT05808764

Muscular Atrophy, Spinal

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RECRUITINGPHASE4

A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy

NCT05861986

Muscular Atrophy, Spinal

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RECRUITING

Natural History of SMA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy

A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy

Natural History of SMA

Adult Spinal Muscular Atrophy (SMA) China Registry

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants

Ultrasound-assisted vs Landmark Based Intrathecal Administration of Nusinersen