Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

NCT03238235 PHASE2 COMPLETED Results posted

Objectives: Primary objective: to establish the histological effects of Givinostat versus placebo administered over 12 months. Secondary Objectives: * To establish the macroscopic muscle effects of Givinostat versus placebo administered over 12 months assessed by Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS). * To determine the other histological effects of Givinostat versus placebo administered over 12 months. * To establish the efficacy of Givinostat versus placebo administered chronically over 12 months in slowing disease progression. * To assess the safety and tolerability of Givinostat versus placebo administered chronically. * To evaluate the pharmacokinetic (PK) profile of Givinostat administered chronically in the target population. * To evaluate the impact of Givinostat versus placebo administered chronically on quality of life and activities of daily living.

Details

Lead sponsor	Italfarmaco
Phase	PHASE2
Status	COMPLETED
Enrolment	51
Start date	Tue Jan 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Mar 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Becker Muscular Dystrophy

Interventions

• Givinostat
• Placebo

Countries

Italy, Netherlands