A Study of the Experimental Medicine Idebenone for Duchenne Muscular Dystrophy (DMD)

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 11 years or older
Gender:
Male
Healthy Volunteers: No
Keywords: Duchenne Muscular Dystrophy, DMD
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
This study is for patients with DMD, who completed the SIDEROS study. The study doctor will determine if you are eligible for this SIDEROS-Extension study.

In this study, a series of physical and laboratory tests will be done. This will check the safety and effectiveness of experimental idebenone. Any side effects will be checked by physical examination, including tests on the heart and by laboratory tests on blood and urine.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be in this research study for up to 19 months. This includes an 18-month treatment period and 1 month of follow-up after you stop treatment.
Recruitment period
From Dec. 14, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Duchenne Muscular Dystrophy