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A study of T19 in subjects with spinal muscular atrophy

T19 shows rapid efficacy in treating patients with type I spinal muscular atrophy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21188633
Enrollment
30
Registered
2023-01-08
Start date
2018-10-05
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Spinal muscular atrophy Nervous System Diseases

Interventions

Spinal muscular atrophy (SMA) is the most common genetic cause of death for children below two years old. Previous studies by us and others have suggested that the fibrinolysis system is involved in n

Sponsors

Talengen Institute of Life Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects were diagnosed with type I SMA with SMN gene mutation or non-5q SMA with mutation in the gene encoding immunoglobulin-binding protein 2 (IGHMBP2), according to genetic tests and clinical symptoms

Exclusion criteria

Exclusion criteria: Patients receiving more than 16 hours of invasive ventilation per day

Design outcomes

Primary

MeasureTime frame
Motor function scores measured using the CHOP INTEND scoring system at baseline and weeks 2, 6, 10, 22 and 46

Secondary

MeasureTime frame
1. Respiratory function measured by the value of blood oxygen saturation without Oxygen inhalation in pulse oximetry at baseline and weeks 2, 6, 10, 22 and 46 2. Anthropometric nutritional status measured using the proportion of high body weight, body fat, and growth parameters at baseline and weeks 10, 22 and 46 3. Adverse events assessed by routine blood test, blood biochemistry, coagulation function, hemolysis function, urine routine test, 12 lead ECG, physical examination, vital signs, etc measured using standard procedures at baseline, and weeks 22 and 46

Countries

China

Contacts

Public ContactChunying Guo
guocy@talengen-pharma.com+86 15167735556

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026