Pediatric Spinal Muscular Atrophy (SMA) China Registry

NCT ID: NCT05042921

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-18

Study Completion Date

2027-09-02

Brief Summary

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The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) treatments among pediatric Chinese participants with spinal muscular atrophy linked to chromosome 5q (5q-SMA). The study will examine SMA natural history and DMT outcomes in a real-world setting both prospectively and retrospectively.

Detailed Description

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Conditions

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Muscular Atrophy, Spinal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DMT Treated Participants

Participants with SMA who received prior treatment with DMTs including nusinersen will be followed prospectively for up to 60 months and the available data is collected retrospectively.

No interventions assigned to this group

Untreated Participants

Participants with SMA who received no treatment will be followed prospectively for up to 60 months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Ability of the participant and/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, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
* Genetically confirmed 5q-SMA.
* Age \< 18 years at enrollment.

Exclusion Criteria

* Unable or unwilling to provide informed consent.
* Other types of SMA (non 5q-SMA).
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Anhui Children's Hospital

Hefei, Anhui, China

Site Status

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Xiamen Maternal and Child Health Hospital

Xiamen, Fujian, China

Site Status

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Shenzhen Children's Hospital

Shenzhen, Guangdong, China

Site Status

Maternity and Child Health Care of Guangxi Zhuang Autonomous Region

Nanning, Guangxi Zhuang, China

Site Status

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Hunan Children's Hospital

Changsha, Hu'nan, China

Site Status

Xiangya Hospital, Central South University

Changsha, Hu'nan, China

Site Status

Wuhan Children's Hospital, Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

Site Status

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Site Status

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Site Status

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

Site Status

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Children's Hospital Affiliated to Shandong University

Jinan, Jinan Shandong, China

Site Status

Dalian Women and Children's Medical Group

Dalian, Liaoning, China

Site Status

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia Hui, China

Site Status

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

The Second Affiliated Hospital of Xi'An Jiaotong University

Xi’an, Shanxi, China

Site Status

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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CN-SMG-11774

Identifier Type: -

Identifier Source: org_study_id

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