DRAGON (Stargardt Disease) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find out if an experimental drug called tinlarebant is a safe and effective option for people with Stargardt Disease.
¿Cuál es la Condición que se está estudiando?
Enfermedad de Stargardt
¿Quién puede participar en el Estudio?
Children and adults ages 12-20 who are diagnosed with Stargardt Disease.
For more information, contact the study team at sim15@duke.edu.
Grupo etario
Adultos, Niños
¿Qué Implica?
If you choose to join this study, you will get a random assignment (like a coin flip) to either take a 5 mg dose of the study drug or a placebo (inactive substance with no drug in it) every day for 24 months. There is a screening period that lasts about 4 weeks to make sure you are eligible to take part in the study. You will visit our clinic for check-ups about 10 times over the course of the study.
Detalles del Estudio
Título Completo
A Phase 1b Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tinlarebant in Japanese Subjects with Stargardt Disease and a Phase 2/3 Randomized, Double-masked, and Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Tinlarebant in Subjects with Stargardt Disease - DRAGON II - LBS-008-CT07
Investigador Principal
Oleg Alekseev, MD, PhD
Especialista en oftalmología
Número de Protocolo
IRB:
PRO00115629
Fase
Phase
II/III
Estado de inscripción
Abierto para inscripción