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MAZDAH: Mazindol in Children With ADHD : Open-label, Efficacy, Safety and Pharmacokinetic Pilot Trial

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00508677
Collaborator
(none)
24
Enrollment
1
Location
16
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    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 :
    Mar 1, 2008
    Actual Primary Completion Date :
    Jul 1, 2009
    Actual Study Completion Date :
    Jul 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      6 Years to 12 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hopital Robert Debre Paris France 75019

      Sponsors and Collaborators

      • Assistance Publique - Hôpitaux de Paris

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00508677
      Other Study ID Numbers:
      • P060104
      First Posted:
      Jul 30, 2007
      Last Update Posted:
      Oct 1, 2009
      Last Verified:
      Jul 1, 2007
      Keywords provided by , ,
      Attention Deficit Hyperactivity Disorder
      Mazindol
      Additional relevant MeSH terms:
      Hyperkinesis
      Attention Deficit Disorder with Hyperactivity

      Study Results

      No Results Posted as of Oct 1, 2009