NCT01918384 - Phase II Study of NPC-14 (Arbekacin Sulfate) to Explore Safety, Tolerability, and Efficacy in Duchenne Muscular Dystrophy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions

Muscular Dystrophy, Duchenne

Interventions

DRUG

NPC-14

"NPC-14 will be administrated as following steps. The dose of NPC-14 will be calculated and adjusted by a non-blinded medical doctor and/or a non-blinded pharmacist.~* An initial dose of NPC-14 will be half of that calculated by distribution volume：Vd based on patient age for safety reason.~* After the initial administration, the dose of NPC-14 will be adjusted and maintained by actual Vd, therapeutic drug monitoring of peak serum levels of NPC-14"

DRUG

Placebo

Dose will be adjusted by volume of distribution (Vd) of patients in accordance with the NPC-14 dose regimen

Trial Locations (4)

650-0017

Kobe university hospital, department of pediatrics, Kobe

663-8501

Hyogo College of Medicine, Nishinomiya

187-8551

National center of neurology and psychiatry, Kodaira

162-8666

Tokyo Women's Medical University, Shinjuku-ku