Mazindol in Children With ADHD : Open-label, Efficacy, Sa... | NCT00508677

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

NCT00508677

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Oct 1, 2009Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 26, 2007

First Submission Date that Met QC Criteria

Jul 26, 2007

First Posted Date

Jul 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2009

Last Update Posted Date

Oct 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

childrens

Sampling Method

Probability Sample

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

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Robert Debre		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided