An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum
This trial is active, not recruiting.
|Conditions||autism, autistic disorder, asperger's disorder, pdd, pervasive developmental disorder|
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Gammaplex 5% IGIV administered intravenously
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
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
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
|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.|
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