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

Information source: IMMUNOe International Research Centers
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism; Autistic Disorder; Asperger's Disorder; PDD; Pervasive Developmental Disorder

Intervention: Gammaplex 5% (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Isaac Melamed

Official(s) and/or principal investigator(s):
Isaac Melamed, MD, Principal Investigator, Affiliation: IMMUNOe International Clinical Research Centers

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 Details

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

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

Primary outcome: The primary objective is to assess the efficacy of Gammaplex as an immunomodulatory therapy in autistic children with evidence of immune dysfunction.

Secondary outcome: The modulatory effect of IVIG on neuroinflammation will be assessed by laboratory measurements which we believe are indicative of immune dysregulation.

Detailed 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.

Eligibility

Minimum age: 4 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

IMMUNOe International Research Centers, Centennial, Colorado 80112, United States
Additional Information

Starting date: June 2013
Last updated: April 15, 2015

Page last updated: August 23, 2015

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