Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)



Status:Recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:11 - Any
Updated:2/8/2019
Start Date:July 4, 2018
End Date:January 2022
Contact:Jodi Wolff
Email:sideros@santhera.com
Phone:+1 (520) 373-0069

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A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study

The purpose of the study is to assess the long-term safety and efficacy of idebenone in
patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

The study will be an open-label, single-group, multi-center extension study in patients with
DMD receiving glucocorticoid steroids who participated in the SIDEROS study and who meet all
the inclusion criteria and none of the exclusion criteria for this extension study.

The study consists of 4 study visits scheduled every 6 months (Visit 1/Baseline, Visit 2/Week
26, Visit 3/ Week 52 and Visit 4/ Week 78). Visit 8/Week 78 in SIDEROS study is also
SIDEROS-E Visit 1/Baseline.

Inclusion Criteria:

1. Completion of the SIDEROS study at Visit 8/ Week 78

2. Signed and dated Informed Consent Form for SIDEROS-E

Exclusion Criteria:

1. Patients who discontinued SIDEROS study prematurely (i.e. did not attend all visits
from V1 to V8)

2. Safety, tolerability or other issues arising during the course of the SIDEROS study
which in the opinion of the Investigator may put the patient at significant risk or
may interfere significantly with the patient's participation in the SIDEROS-E study

3. Use of any investigational drug other than the study medication
We found this trial at
4
sites
Leuven,
Principal Investigator: Gunnar Buyse, MD
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Leuven,
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Birmingham, Alabama 35294
Principal Investigator: Robert B. Troxler, MD
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Birmingham, AL
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Sacramento, California 95817
Principal Investigator: Craig McDonald, MD
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Sacramento, CA
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Saint Paul, Minnesota 55101
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from
Saint Paul, MN
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