Clinical Trial Results:
An Open-Label, Dose Escalation and Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Tolerability of Sepofarsen in Pediatric Subjects <8 Years of Age with Leber Congenital Amaurosis Type 10 (LCA10) due to the c.2991 +1655A>G (p.Cys998X) mutation
Summary
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EudraCT number |
2020-000535-45 |
Trial protocol |
BE DE GB NL IT |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Dec 2022
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First version publication date |
15 Dec 2022
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Other versions |
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Summary report(s) |
PQ-110-005 (Brighten)_CTSR |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.