Trial of Low-Dose Naltrexone for Children With Pervasive... | NCT00318162

Studies
Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)

NCT00318162

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

May 3, 2006Estimated

Enrollment

50Estimated

Phase

Phase 1Phase 2

Conditions

Pervasive Developmental Disorder

Interventions

low dose naltrexone

Countries

Israel

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

Apr 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 25, 2006

First Submission Date that Met QC Criteria

Apr 25, 2006

First Posted Date

Apr 26, 2006Estimated

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

May 2, 2006

Last Update Posted Date

May 3, 2006Estimated

Name	Class
Jerusalem Institute for Child Development	UNKNOWN

Description Module

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.

Detailed Description

Fifty children aged three to six years will be recruited for the study. They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over. Assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.

Design Module

Study Type

Interventional

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
low dose naltrexone	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of PDD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David S Wilensky, MD	Contact	97227828142		davidvil@012.net.il

Overall Officials

Name	Affiliation	Role
David S Wilensky, MD	Jerusalem Institute for Child Development	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jerusalem Institute for Child Development		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D000067877	Autism Spectrum Disorder

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009271	Naltrexone

Ancestor Terms

ID	Term
D009270	Naloxone
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
play observation
Autism Behavior Checklist (ABC) questionnaire