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

Autism Clinical Trial

Official title: A Phase IV, Single-site, Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

We have come to believe that an immature immune system with abnormal signaling and altered apoptotic pathways may result in a process of neuroinflammation with a clinical presentation of Autism Spectrum Disorder. If Autism Spectrum Disorders are the consequence of a chronic inflammatory process that prevents the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. We believe that there is a correlation between immunological abnormalities and the development of the autism. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Syndrome
• Asperger's Disorder
• Autism
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Disease
• PDD
• Pervasive Developmental Disorder

• NCT number: NCT02199925
• Study type: Interventional
• Source: IMMUNOe International Research Centers
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 2013
• Completion date: July 2015