This trial is active, not recruiting.

Conditions autism, autistic disorder, asperger's disorder, pdd, pervasive developmental disorder
Treatment gammaplex 5%
Phase phase 4
Sponsor Isaac Melamed
Collaborator Bio Products Laboratory
Start date June 2013
End date April 2015
Trial size 30 participants
Trial identifier NCT02199925, GMXAUT01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Gammaplex 5% IGIV administered intravenously
gammaplex 5%

Primary Outcomes

The primary objective is to assess the efficacy of Gammaplex as an immunomodulatory therapy in autistic children with evidence of immune dysfunction.
time frame: 1 year

Secondary Outcomes

The modulatory effect of IVIG on neuroinflammation will be assessed by laboratory measurements which we believe are indicative of immune dysregulation.
time frame: 1 year

Eligibility Criteria

Male or female participants from 4 years up to 12 years old.

Inclusion Criteria: - The subject is between the ages of or equal to 4 and 12 years of age, of either gender, and belonging to any ethnic group. - The subject has a diagnosis, for a minimum of 6 months prior to screening, of either autistic disorder, Asperger disorder, or pervasive developmental disorder (PDD). - Normal physical test results. - Immunological lab results showing reduced levels of activated CD40L or abnormal lymphocyte stimulation, or T or B cell dysfunction (hypgammaglobulinemia, primary immunodeficiency (PIDD), or common variable immune deficiency (CVID). Exclusion Criteria: - A diagnosis of isolated IGA deficiency - Allergic reactions to blood products

Additional Information

Official title A Phase IV, Single-site, Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum
Principal investigator Isaac Melamed, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by IMMUNOe International Research Centers.