Flavocoxid in DMD

Safety examine of Flavocoxid in Duchenne Muscular Dystrophy
This examine is currently recruiting participants.
Verified on April 2011 by university of Messina

First received on April 12, 2011. final updated on April 13, 2011 history of adjustments
Sponsor: university of Messina
Information supplied by: university of Messina
ClinicalTrials.gov Identifier: NCT01335295

purpose
Objective of this examine is to evaluate safety and tolerability of flavocoxid administered with the every day oral dosage of 500 or 1000 mg/die for one particular yr in DMD patients, by yourself or in association with steroids (deflazacort on alternate days) started at least one particular yr before. The investigators may also complete a multidimensional medical evaluation covering functional and muscle strength and quality of life (QoL)assessments.

Condition Intervention phase
Duchenne Muscular Dystrophy
Drug: Flavocoxid
phase I

Study Type: Interventional
Study Design: Endpoint Classification: safety Study
Intervention Model: one group Assignment
Masking: open label
Official Title: open Pilot sample to test the safety and Tolerability of Flavocoxid in Duchenne Muscular Dystrophy

Further examine particulars as supplied by university of Messina:

Primary outcome Measures:
All adverse events and laboratory or ECG abnormalities [ Time Frame: one yr ] [ Designated as safety issue: certainly ]

Secondary outcome Measures:
Motor assessments and biochemical evaluation [ Time Frame: one yr ] [ Designated as safety issue: No ]
Outcome actions will include:

Functional tests: 6- moment walk test, North Star Ambulatory Assessment (NSAA) with timed items
Medical homework Council (MRC) rating of top and reduce limbs;
Maximum voluntary isometric contraction (MVIC)
Quality of life (QoL) evaluation ;
Forced vital capability (FVC) with spirometer . adjustments in biomarkers

Estimated Enrollment: twenty
Study start Date: March 2011
Estimated examine Completion Date: December 2012
Estimated main Completion Date: October 2012 (Final details collection date for main outcome measure)

Intervention Details:
Drug: Flavocoxid
Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for one year
Eligibility

Ages qualified for Study: four years to 16 years
Genders qualified for Study: man
Accepts healthy and balanced Volunteers: No

Criteria
Inclusion Criteria:

clinical diagnosis of DMD, confirmed by muscle biopsy and molecular analysis by MPLA;
range of age between four -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, brief leg braces, extensive leg braces or walkers) is just not permitted.
follow-up of at least one yr before baseline while using selected motor outcome measures;
patients in a position to complete evaluation tests;
patient legally authorized representative (LAR) in a position to have an understanding of and give the informed consent;
absence of contra-indications to using 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 three months earlier to start of examine treatment;
exposure to an additional investigational drug or supplements within 2 months earlier to start of examine treatment;
presence of cognitive impairment that could influence the efficiency on the evaluation tests;
history of main surgical procedure within thirty days earlier to start of examine treatment;
expectation of main surgical procedure (eg, scoliosis surgery) during the 12-month treatment period of time on the study;
ongoing participation in another therapeutic medical study;
expectation of recruitment while in the forthcoming exon-51 trial;
requirement for daytime ventilator assistance;
presence of liver-diseases or assumption of any hepatotoxic agent;
screening laboratory beliefs out on the laboratory ranges if clinically meaningful;
prior or ongoing medical issue (eg, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, while in the investigator’s opinion, could adversely affect the safety on the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of examine results.

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