Trial intelligence / Profile preview

LILAC: Trofinetide Open-Label Extension in Rett Syndrome

NCT04279314Phase 3Completed

Sponsor
Acadia Pharmaceuticals
Start
Jan 2020
Primary completion
Aug 2022
Modality
Peptides, Small Molecules
Countries
1
01

Overview

Phase 3, open-label, single-arm trial of trofinetide in Rett syndrome (RTT), sponsored by Acadia Pharmaceuticals. Primary endpoints: Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs at 40 weeks, Subjects With Post-baseline Potentially Clinically Important Changes in ECG at 40 weeks and 3 more. Started Jan 2020; status: completed.

02

Drugs

trofinetide
03

Conditions

Rett syndrome (RTT)

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