Clinical Trial: Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single-Blind, Phase 2 Study To Evaluate The Safety And Efficacy Of Tideglusib 400mg Or 1000mg For The Treatment Of Adolescent And Adult Congenital And Juvenile-Onset Myotonic D

Brief Summary: The purpose of this study is to determine whether Tideglusib is safe and efficacious in the treatment of adolescents and adults with congenital and juvenile-onset Myotonic Dystrophy. The pharmacokinetics of tideglusib and its primary metabolite will also be investigated.

Detailed Summary: The study is currently open for enrolment at the Newcastle Upon Tyne Hospitals NHS Trust for subjects aged between 16-45 years
Sponsor: AMO Pharma Limited

Current Primary Outcome: Incidence of adverse events (AEs), including serious adverse events (SAEs), will be compared across two dose levels of tideglusib. SAEs and AEs will be examined throughout the study. [ Time Frame: 14 weeks (baseline through end of study) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AMO Pharma Limited

Dates:
Date Received: August 4, 2016
Date Started:
Date Completion:
Last Updated: March 15, 2017
Last Verified: March 2017