Safety Study of Flavocoxid in Duchenne Muscular Dystrophy

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. Identifier: NCT01335295
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : February 3, 2014
Information provided by (Responsible Party):
Giuseppe Vita, University of Messina

April 12, 2011
April 14, 2011
February 3, 2014
March 2011
December 2013   (Final data collection date for primary outcome measure)
All adverse events and laboratory or ECG abnormalities [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01335295 on Archive Site
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
Same as current
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Safety Study of Flavocoxid in Duchenne Muscular Dystrophy
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Duchenne Muscular Dystrophy
Drug: Flavocoxid
Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for 1 year
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
4 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Giuseppe Vita, University of Messina
University of Messina
Not Provided
Principal Investigator: Giuseppe Vita, MD Department of Neuroscience, University of Messina
University of Messina
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP