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
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | July 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 12 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | IMMUNOe International Research Centers | Centennial | Colorado |
Lead Sponsor | Collaborator |
---|---|
Isaac Melamed | Bio Products Laboratory |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To improve development in autistic spectrum | 1 year | No | |
Primary | The primary objective is to assess the efficacy of Gammaplex as an immunomodulatory therapy in autistic children with evidence of immune dysfunction. | The primary endpoint is disease improvement, as evidenced by standardized test measures across 3 intervals: screening for baseline measurements, visit 5, and end of study visit measurements. Primary efficacy variables will be measured using the following standardized tests Caregiver Scales (SRS, CCC-2, ABC) CGI-S and CGI - I PPVT ADOS |
1 year | No |
Secondary | The modulatory effect of IVIG on neuroinflammation will be assessed by laboratory measurements which we believe are indicative of immune dysregulation. | 1 year | No |
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