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A study of plasminogen in subjects with spinal muscular atrophy

Not Applicable
Completed
Conditions
Spinal muscular atrophy
Nervous System Diseases
Registration Number
ISRCTN21188633
Lead Sponsor
Talengen Institute of Life Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
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

Patients receiving more than 16 hours of invasive ventilation per day

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Motor function scores measured using the CHOP INTEND scoring system at baseline and weeks 2, 6, 10, 22 and 46
Secondary Outcome Measures
NameTimeMethod
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<br>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<br>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
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