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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01153932
Other study ID # 114117
Secondary ID
Status Completed
Phase Phase 2
First received June 29, 2010
Last updated August 21, 2014
Start date September 2010
Est. completion date September 2012

Study information

Verified date August 2013
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether GSK2402968 given as a continuous dose and as an intermittent dose is effective and safe in the treatment of Duchenne muscular dystrophy.


Description:

This is a phase II, double-blind, exploratory, parallel-group, placebo-controlled clinical study in ambulant subjects with DMD resulting from a mutation that can be corrected by exon skipping induced by GSK2402968. The study aims to randomise 54 subjects. There will be 2 parallel cohorts. Each cohort will include subjects on GSK2402968 and matched placebo in a 2:1 ratio.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GSK2402968
Subcutaneous injection
matched placebo
Subcutaneous injection

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Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Belgium,  France,  Germany,  Israel,  Netherlands,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD 48 weeks
Secondary To assess the safety and tolerability of 2 different dosing regimens of subcutaneous GSK2402968 administered over 48 weeks in ambulant subjects one year
Secondary To assess the PK of 2 different dosing regimens of subcutaneous GSK2402968 administered over 48 weeks in ambulant subjects with DMD 48 weeks
Secondary To assess long term efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 48 weeks in ambulant subjects with DMD one year
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