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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02199925
Other study ID # GMXAUT01
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received July 21, 2014
Last updated April 15, 2015
Start date June 2013
Est. completion date July 2015

Study information

Verified date March 2015
Source IMMUNOe International Research Centers
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

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


Intervention

Drug:
Gammaplex 5%


Locations

Country Name City State
United States IMMUNOe International Research Centers Centennial Colorado

Sponsors (2)

Lead Sponsor Collaborator
Isaac Melamed Bio Products Laboratory

Country where clinical trial is conducted

United States, 

Outcome

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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