Mazindol in Children With ADHD : Open-label, Efficacy, Safety and Pharmacokinetic Pilot Trial (MAZDAH)
This prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.
Attention Deficit Hyperactivity Disorder
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Mazindol in Children With Attention Deficit Hyperactivity Disorder Design Study to Explore the Effectiveness, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Orally Administered Doses of Mazindol.|
|Study Start Date:||March 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
The most common intervention for Attention Deficit Hyperactivity Disorder (ADHD) is pharmacological treatment with methylphenidate (MPH). Effects of MPH on ADHD symptoms in children is extremely well-informed. Mazindol is a psychostimulant and a wake-promoter agent which may have similar actions to MPH in the central nervous system. However, there is no record of the effects, safety, tolerability of Mazindol in children with ADHD. Mazindol (dose 0.5 or 1.0 mg/day) should prove to be useful in the treatment of ADHD symptoms in children. Based on clinical assessments and serum concentrations after oral administration of mazindol to children (6-12 years) with ADHD, this prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.
|Hopital Robert Debre|
|Paris, France, 75019|
|Principal Investigator:||Eric KONOFAL, MD-PH||Assistance Publique - Hôpitaux de Paris|