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.”

This prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: April 2009

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.

Inclusion Criteria:

• Subjects can be boys or girls
• Subjects must be aged between 6 to 12 years,
• Tanner 1 ou 2
• Subjects with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) criteria
• ADHD-RS score of ≥ 31 as determined by investigator at screening visit.
• Drug free including psychostimulants (10 days before the screening visit)
• Informed Consent Form signed by the subject and both parents
• Healthy on the basis of a physical examination, medical history and the results of blood hematology tests.

Exclusion Criteria:

• Any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, obsessive-compulsive disorder (OCD), autism or Asperger…
• Sleep Disorders including narcolepsy, hypersomnia (according to International
• Classification of Sleep Disorders (ICSD) criteria
• Chronic diseases (e.g. asthma…)
• Current eating disorder (e.g. bulimia, anorexia nervosa) or history of an eating disorder during infancy
• Mental retardation (IQ < 80)
• Hyperthyroidism
• Subjects with history of seizures, glaucoma or familial hypertension
• Heart pathologies

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

Eric KONOFAL, MD-PH Principal Investigator Assistance Publique - Hôpitaux de Paris  

Overall Contact: Eric KONOFAL, MD-PH +33 (0)1 40 03 22 63 eric.konofal@rdb.aphp.fr

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00508677

Study ID Number: P060104

ClinicalTrials.gov Identifier: NCT00508677

Health Authority: France: Ministry of Health