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Prospective Observational Study on the Method to Assess the Efficacy of Risdiplam on Manual Dexterity in Patients with Spinal Muscular Atrophy

Not Applicable
Recruiting
Conditions
Spinal Muscular Atrophy
Registration Number
JPRN-UMIN000045717
Lead Sponsor
CHUGAI PHARMACEUTICAL CO.LTD.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

<Cohort A> (1) Patients who have received Nusinersen <Cohort A and Cohort B> (1) Patients who have received Risdiplam <Cohort A, Cohort B and Cohort C> (1) Patients who have received Onasemnogene abeparvovecor other SMN2 modifiers (2) Patients who are receiving valproic acid. (3) Patients who have undergone surgery for scoliosis or hip arthrodesis within 6 months before screening or are scheduled to undergo within 18 months after screening (4) Patients who require invasive ventilation or tracheostomy (5) Patients who are judged by the investigator to have a disease other than SMA that causes functional decline in the upper limbs (6) Patients who are judged by the investigator not to be suitable for this study for any reason

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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