Dettagli per singolo studio

DEC-NET Serial number FR583

Published online	12/10/2006 11.11.00
Last updated	12/10/2006 11.10.43

Other protocol ID number	-
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	Muscular dystrophies and other myopathies
Experimental drug
L-Glutamine Treatment regimen (dosage and duration) Oral glutamine intake (0.5g/kg/d) includes two 4-month périods separated by a 1 month wash-out period.
Gender	Male
Age (range)	2-8 years old
Eligibility criteria
Inclusion criteria
-Clinical diagnosis of Duchenne muscular dystrophy -Able to walk > 170 m -Absence of hepatic and renal insuffiency
Exclusion criteria
-Dependent upon whellchair -Body weight > 60kg -Surgery scheduled during the year following the first visit
Trial design/methodology
Phase	2
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind Cross-over Prospective Study
Purpose of study
Primary Objectif: -To compare the walking speed in Duchenne dystrophy muscular children receiving oral glutamine or placebo by random sampling. Secondary objective: -To evaluate the effect of glutamine on the muscular mass, indices of protein metabolism and body composition.
Primary outcomes
-Walking speed on a standard course at M0,M2, M4, M5, M7, M9
Secondary outcomes
-Work (kcal)and power(kcal/s)in relation to effort -Body composition ( biophotonic absorptiometry and bioelectrical impedance analysis) -Indices of protein degradation (CPK and 3 methyl histidine excretion) Muscle mass (24 h urinary creatinine excretion)
Summary of study design, objectives, and ongoing research findings
This multi-site national study aims to evaluate the functional benefit of long-term oral glutamine administration in 30 DMD children using a randomized double-blind placebo-controlled cross-over design. The study includes two 4-month periods: 1) a treatment period in which the subject receives oral glutamine (0.5 g/kg/d) and 2) a control period in which the subject receives a placebo. The two 4-month periods are separated by a 1 month wash-out period. The children are monitored every 2 months during periods 1 and 2 in the clinical investigation centres of Hôpital Robert Debré in Paris and the CHR&U de Lille, as well as the clinical research centre of the CHU de Poitiers. Evidence of a functional benefit would involve evaluating the administration of glutamine over longer periods.