NCT00318162

Brief Summary

This study will examine the effects of low-dose naltrexone (LDN) on children with autistic spectrum disorders. The investigators hope to show a positive effect on social functioning and language.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
Last Updated

May 3, 2006

Status Verified

April 1, 2006

First QC Date

April 25, 2006

Last Update Submit

May 2, 2006

Conditions

Keywords

autismPDDLDNnaltrexone

Outcome Measures

Primary Outcomes (2)

  • play observation

  • Autism Behavior Checklist (ABC) questionnaire

Interventions

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of PDD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jerusalem Institute for Child Development

Jerusalem, Israel

Location

MeSH Terms

Conditions

Child Development Disorders, PervasiveAutistic Disorder

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersAutism Spectrum Disorder

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • David S Wilensky, MD

    Jerusalem Institute for Child Development

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David S Wilensky, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 26, 2006

Last Updated

May 3, 2006

Record last verified: 2006-04

Locations