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A prospective, non-randomized, open-label, controlled cohort study comparing the safety of Vamorolone and prednisone in the treatment of children with Duchenne muscular dystrophy

A prospective, non-randomized, open-label, controlled cohort study comparing the safety of Vamorolone and prednisone in the treatment of children with Duchenne muscular dystrophy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120502
Enrollment
Unknown
Registered
2026-03-16
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchnenne muscular dystrophy

Interventions

Vamorolone group:None
Control group:None

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) Males aged 4 - 12 years old. 2) Diagnosed with DMD through genetic testing. 3) Able to walk independently (6 - Minute Walk Test > 120 meters). 4) Have not used hormones or have been using hormones stably for >= 6 months. 5) Guardians have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Combination with other serious diseases (such as severe heart disease, liver and kidney dysfunction). 2) History of serious adverse reactions to previous hormone therapy. 3) Inability to complete follow - up evaluation.

Design outcomes

Primary

MeasureTime frame
Height;Weight;Bone mineral density;—

Secondary

MeasureTime frame
NSAA;6-minute Gait, 6MWT;—

Countries

China

Contacts

Public ContactLifei Yu, Chaoping Hu

Children's Hospital of Fudan University

guyuehuchaoping@163.com+86 135 2443 9064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026