Status:
WITHDRAWN
A Retrospective, Natural History Study in Children With CLN2
Lead Sponsor:
REGENXBIO Inc.
Conditions:
Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)
Eligibility:
All Genders
Brief Summary
This is a multi center, retrospective, chart review study to document the evolution of ocular disease progression in pediatric patients with CLN2.
Detailed Description
CLN2 is a rare disease with limited available ocular natural history data. While current standard of care slows motor degeneration, it is not known to treat the ocular manifestations of disease. This ...
Eligibility Criteria
Inclusion
- A participant is eligible to be included in the study only if all of the following criteria apply:
- The participant's legal guardian(s) is(are) willing and able to provide them written, signed informed consent.
- The participant has a documented diagnosis of CLN2 disease due to TPP1 deficiency, or has a relative clinically diagnosed with CLN2 disease who has the same CLN2 mutations as the participant
- The participant has had one or more eye examinations by an eye care specialist at any time since birth.
Exclusion
- No exclusion criteria apply to this study.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04480476
Start Date
March 31 2021
End Date
April 1 2022
Last Update
November 1 2021
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