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An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum

NCT02199925 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-16

No results posted yet for this study

Summary

If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.

Conditions

  • Autism
  • Autistic Disorder
  • Asperger's Disorder
  • PDD
  • Pervasive Developmental Disorder

Interventions

DRUG

Gammaplex 5%

Sponsors & Collaborators

  • Bio Products Laboratory

    collaborator OTHER

  • Isaac Melamed

    lead INDUSTRY

Principal Investigators

  • Isaac Melamed, MD · IMMUNOe International Clinical Research Centers

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-04-30
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02199925 on ClinicalTrials.gov