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Safety Study of Flavocoxid in Duchenne Muscular Dystrophy

This study has been completed.
Information provided by (Responsible Party):
Giuseppe Vita, University of Messina Identifier:
First received: April 12, 2011
Last updated: January 31, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Duchenne Muscular Dystrophy
Drug: Flavocoxid
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Open Pilot Trial to Test the Safety and Tolerability of Flavocoxid in Duchenne Muscular Dystrophy

Resource links provided by NLM:

Further study details as provided by University of Messina:

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

Enrollment: 20
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Flavocoxid
    Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for 1 year

Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01335295

Department of Neuroscience, Psychiatry and Anestesiology, Policlinico of Messina
Messina, ME, Italy, 98125
Sponsors and Collaborators
University of Messina
Principal Investigator: Giuseppe Vita, MD Department of Neuroscience, University of Messina
  More Information

Responsible Party: Giuseppe Vita, full professor, University of Messina Identifier: NCT01335295     History of Changes
Other Study ID Numbers: DMD-2011
Study First Received: April 12, 2011
Last Updated: January 31, 2014

Keywords provided by University of Messina:
Duchenne muscular dystrophy
pilot study

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked processed this record on April 28, 2017