Patient with ADHD diagnosis criterion. The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach

Patient with symptom of hyperactivity and/or attention deficiency but without ADHD diagnosis criterion.
The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach.

Adhd

Biological samples (blood and urine) for a multimodal metabolomic approach

Metabolomic approach

University Hospital TOURS

Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children

Detection of metabolites (phenylalanine or catécholamines) in the blood of patients with ADHD at levels significantly different from baseline levels in the general population and rates found in patients with attention deficit and / or hyperactivity disorders but that multidisciplinary assessment excludes the diagnosis of ADHD.

Detection of metabolites (phenylalanine or catécholamines) in the urine of patients with ADHD at levels significantly different from baseline levels in the general population and rates found in patients with attention deficit and / or hyperactivity disorders but that multidisciplinary assessment excludes the diagnosis of ADHD.

University Hospital, Tours

Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d

Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d.

Participants receive a matched dose placebo, given orally twice daily, in combination with riluzole at 50 mg b.i.d.

Amyotrophic Lateral Sclerosis

Masitinib (6.0)

Riluzole

Placebo

Masitinib (4.5)

Department of Neurology ,University of Ulm

Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised.

Change in ALS quality of life patient questionnaire (ALSAQ-40)

Progression free survival (PFS) is defined as the time from randomization to progression (decline of more than 9 points in ALSFRS-R score from baseline) or death

Change in evaluation of upper- and lower-limb muscle strength using hand-held dynamometry (HHD)

AB Science

Amyotrophic Lateral Sclerosis (ALS)

Masitinib (3.0)

Hospital Carlos III

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

The amyotrophic lateral sclerosis functional rating scale (ALSFRS), which is a Validated instrument that assesses the functional status and the disease progression in patients with amyotrophic lateral sclerosis (ALS)

Forced vital capacity (FVC) measures the volume of air expelled from the lungs during a quick, forceful breath.

Progression Free Survival is defined as the time from the randomization date until the earliest date for a decline of more than 9-points in ALSFRS-R score

Overall survival is defined as time in months from the randomization date to the date of death due to any cause.

amyotrophic lateral sclerosis/tyrosine

Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children

Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

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