Investigating NMJ Defects in SMA Following Central and Peripheral SMN Restoration

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is an observational study to investigate the improvement of NMJ defects in adult patients with SMA following treatment with Risdiplam. Eligible patients will have received treatment with daily oral Risdiplam after receiving approval through their commercial insurance or drug assistance program. All subjects will be evaluated at one visit. Eligible subjects must have been receiving risdiplam for at least 12 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Signed Informed Consent Form

• Age 18-70 years at time of signing Informed Consent Form

• Able and willing to provide written informed consent and to comply with the program protocol according to ICH and local regulations

• Ability to comply with the study protocol, in the investigator's judgment

• Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate, in the opinion of the treating physician

• Patients with retinopathy of prematurity should have evidence of stable disease

• Genetic confirmation of 5q SMA documented on standard genetic tests for the disorder

• Treated with risdiplam for a duration of 12 months or longer

Locations
United States
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Contact Information
Primary
Gia Cinkay
Georgia.Cinkay@osumc.edu
614-366-9050
Backup
Marco Tellez, CCRP
Marco.Tellez@osumc.edu
614-688-7837
Time Frame
Start Date: 2021-10-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Sponsors
Collaborators: Genentech, Inc.
Leads: Bakri Elsheikh

This content was sourced from clinicaltrials.gov