Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)
Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
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
CompletedFirst Posted
Study publicly available on registry
April 26, 2006
CompletedMay 3, 2006
April 1, 2006
April 25, 2006
May 2, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
play observation
Autism Behavior Checklist (ABC) questionnaire
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David S Wilensky, MD
Jerusalem Institute for Child Development
Central Study Contacts
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