- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01335295
Safety Study of Flavocoxid in Duchenne Muscular Dystrophy
January 31, 2014 updated by: Giuseppe Vita, University of Messina
Open Pilot Trial to Test the Safety and Tolerability of Flavocoxid in Duchenne Muscular Dystrophy
Objective of this study is to evaluate safety and tolerability of flavocoxid administered at the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in association with steroids (deflazacort on alternate days) started at least one year before.
The investigators will also perform a multidimensional clinical evaluation covering functional and muscle strength and quality of life (QoL)assessments.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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ME
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Messina, ME, Italy, 98125
- Department of Neuroscience, Psychiatry and Anestesiology, Policlinico of Messina
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- clinical diagnosis of DMD, confirmed by muscle biopsy and molecular analysis by MPLA;
- range of age between 4 -16 years;
- unaided ambulation for at least 75 meters, unassisted during the Screening 6MWT. Other personal assistance or use of assistive devices for ambulation (eg, short leg braces, long leg braces or walkers) is not permitted.
- follow-up of at least 1 year before baseline with the selected motor outcome measures;
- patients able to perform evaluation tests;
- patient legally authorized representative (LAR) able to understand and give the informed consent;
- absence of contra-indications to the use of flavocoxid (see below);
- written informed consent signed by LAR.
Exclusion Criteria:
- treatment with other drugs analogue, similar or interacting with flavocoxid or immunosuppressive therapy (other than corticosteroids) within 3 months prior to start of study treatment;
- exposure to another investigational drug or supplements within 2 months prior to start of study treatment;
- presence of cognitive impairment that could influence the performance of the evaluation tests;
- history of major surgical procedure within 30 days prior to start of study treatment;
- expectation of major surgical procedure (eg, scoliosis surgery) during the 12-month treatment period of the study;
- ongoing participation in any other therapeutic clinical study;
- expectation of recruitment in the forthcoming exon-51 trial;
- requirement for daytime ventilator assistance;
- presence of liver-diseases or assumption of any hepatotoxic agent;
- screening laboratory values out of the laboratory ranges if clinically meaningful;
- prior or ongoing medical condition (eg, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All adverse events and laboratory or ECG abnormalities
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor assessments and biochemical evaluation
Time Frame: 1 year
|
Outcome measures will include:
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giuseppe Vita, MD, Department of Neuroscience, University of Messina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
April 12, 2011
First Submitted That Met QC Criteria
April 13, 2011
First Posted (Estimate)
April 14, 2011
Study Record Updates
Last Update Posted (Estimate)
February 3, 2014
Last Update Submitted That Met QC Criteria
January 31, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMD-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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