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

Status unconfirmed · Phase 4

Conditions studied: Autism, Autistic Disorder, Asperger's Disorder, PDD, Pervasive Developmental Disorder

In brief

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.

Key facts

Study ID

NCT02199925

Run by

Isaac Melamed

People needed

30

Starts

2013-06-01

Expected to finish

2015-07-01

Last updated by the study team

2015-04-16

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• A diagnosis of isolated IGA deficiency
• Allergic reactions to blood products

Where it is running

• IMMUNOe International Research Centers — Centennial, Colorado, United States

Full record on ClinicalTrials.gov

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