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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00823368
Other study ID # 22001A
Secondary ID
Status Completed
Phase N/A
First received January 13, 2009
Last updated July 30, 2013
Start date January 2009

Study information

Verified date July 2013
Source Seaside Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 40 Years
Eligibility Inclusion Criteria:

- Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Exclusion Criteria:

- Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
STX209


Locations

Country Name City State
United States University of North Carolina Neurosciences Hospital Chapel Hill North Carolina
United States Rush University Medical Center Chicago Illinois
United States Red Oaks Psychiatry Associates, PA Houston Texas
United States Riley Hospital for Children Indianapolis Indiana
United States University of California-Los Angeles Neuropsychiatric Institute Los Angeles California
United States Suburban Research Associates Media Pennsylvania
United States Vanderbilt Kennedy Center Nashville Tennessee
United States Southwest Autism Research & Resource Center Phoenix Arizona
United States M.I.N.D. Institute Sacramento California
United States Seattle Children's Hospital Seattle Washington
United States NYS Institute for Basic Research in Developmental Disabilities Staten Island New York

Sponsors (1)

Lead Sponsor Collaborator
Seaside Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in plasma proteins with treatment After 4 weeks of treatment No
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