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
|