Trial record 13 of 207 for:
"muscular dystrophy, duchenne and becker types"
Safety Study of Flavocoxid in Duchenne Muscular Dystrophy
This study has been completed.
First Posted: April 14, 2011
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Information provided by (Responsible Party):
Giuseppe Vita, University of Messina
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.
Duchenne Muscular Dystrophy
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
||Open Pilot Trial to Test the Safety and Tolerability of Flavocoxid in Duchenne Muscular Dystrophy
Primary Outcome Measures:
- All adverse events and laboratory or ECG abnormalities [ Time Frame: 1 year ]
Secondary Outcome Measures:
- Motor assessments and biochemical evaluation [ Time Frame: 1 year ]
Outcome measures will include:
- Functional tests: 6- minute walk test, North Star Ambulatory Assessment (NSAA) with timed items
- Medical Research Council (MRC) score of upper and lower limbs;
- Maximum voluntary isometric contraction (MVIC)
- Quality of Life (QoL) evaluation ;
- Forced vital capacity (FVC) with spirometer . Changes in biomarkers
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:
||4 Years to 16 Years (Child)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335295
|Department of Neuroscience, Psychiatry and Anestesiology, Policlinico of Messina
|Messina, ME, Italy, 98125 |
University of Messina
||Giuseppe Vita, MD
||Department of Neuroscience, University of Messina
||Giuseppe Vita, full professor, University of Messina
History of Changes
|Other Study ID Numbers:
||April 12, 2011
||April 14, 2011
|Last Update Posted:
||February 3, 2014
Keywords provided by Giuseppe Vita, University of Messina:
Duchenne muscular dystrophy
Additional relevant MeSH terms:
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked